ethinylestradiol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| estrogens | 1082 | 57-63-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A semisynthetic alkylated ESTRADIOL with a 17-alpha-ethinyl substitution. It has high estrogenic potency when administered orally, and is often used as the estrogenic component in ORAL CONTRACEPTIVES.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 25 | mcg | O |
| 1.50 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 3 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.10 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 40 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 4.30 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 7 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.01 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 9.70 hours | Lombardo F, Berellini G, Obach RS |
| S (Water solubility) | 0.01 mg/mL | Bocci G, Oprea TI, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 25, 1943 | FDA | SCHERING | |
| July 23, 2010 | PMDA | Bayer Yakuhin |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Pulmonary embolism | 862.97 | 17.88 | 434 | 12315 | 116250 | 63360023 |
| Unintended pregnancy | 678.65 | 17.88 | 172 | 12577 | 6007 | 63470266 |
| Intermenstrual bleeding | 589.51 | 17.88 | 162 | 12587 | 7764 | 63468509 |
| Device expulsion | 478.60 | 17.88 | 200 | 12549 | 34722 | 63441551 |
| Deep vein thrombosis | 443.59 | 17.88 | 250 | 12499 | 83550 | 63392723 |
| Inappropriate schedule of product administration | 339.65 | 17.88 | 228 | 12521 | 103737 | 63372536 |
| No adverse event | 319.41 | 17.88 | 159 | 12590 | 41246 | 63435027 |
| Incorrect product administration duration | 301.93 | 17.88 | 106 | 12643 | 11440 | 63464833 |
| Pregnancy with contraceptive device | 276.48 | 17.88 | 80 | 12669 | 4614 | 63471659 |
| Product quality issue | 208.50 | 17.88 | 114 | 12635 | 35751 | 63440522 |
| Medical device discomfort | 173.98 | 17.88 | 46 | 12703 | 1893 | 63474380 |
| Heavy menstrual bleeding | 154.12 | 17.88 | 74 | 12675 | 17699 | 63458574 |
| Vulvovaginal discomfort | 142.10 | 17.88 | 41 | 12708 | 2337 | 63473936 |
| Vaginal discharge | 130.23 | 17.88 | 54 | 12695 | 9144 | 63467129 |
| Abortion induced | 114.90 | 17.88 | 51 | 12698 | 10191 | 63466082 |
| Abnormal withdrawal bleeding | 97.08 | 17.88 | 16 | 12733 | 52 | 63476221 |
| Cerebral venous sinus thrombosis | 87.42 | 17.88 | 27 | 12722 | 1945 | 63474328 |
| Device breakage | 84.97 | 17.88 | 43 | 12706 | 11499 | 63464774 |
| Hypercoagulation | 81.79 | 17.88 | 26 | 12723 | 2059 | 63474214 |
| Device failure | 80.75 | 17.88 | 34 | 12715 | 5977 | 63470296 |
| Thrombosis | 80.36 | 17.88 | 81 | 12668 | 64674 | 63411599 |
| Vulvovaginal mycotic infection | 76.50 | 17.88 | 32 | 12717 | 5534 | 63470739 |
| Abortion spontaneous | 75.62 | 17.88 | 68 | 12681 | 47127 | 63429146 |
| Ectopic pregnancy | 72.58 | 17.88 | 25 | 12724 | 2542 | 63473731 |
| Menstruation irregular | 72.58 | 17.88 | 33 | 12716 | 6971 | 63469302 |
| Product shape issue | 70.92 | 17.88 | 13 | 12736 | 89 | 63476184 |
| Withdrawal bleed | 69.90 | 17.88 | 12 | 12737 | 53 | 63476220 |
| Cervical dysplasia | 67.09 | 17.88 | 25 | 12724 | 3189 | 63473084 |
| Dysmenorrhoea | 65.41 | 17.88 | 26 | 12723 | 3947 | 63472326 |
| Vaginal haemorrhage | 63.59 | 17.88 | 49 | 12700 | 27438 | 63448835 |
| Menstruation delayed | 61.43 | 17.88 | 20 | 12729 | 1709 | 63474564 |
| Pulmonary infarction | 59.66 | 17.88 | 22 | 12727 | 2725 | 63473548 |
| Night sweats | 55.01 | 17.88 | 58 | 12691 | 48756 | 63427517 |
| Amenorrhoea | 53.40 | 17.88 | 30 | 12719 | 9884 | 63466389 |
| Muscle spasticity | 52.93 | 17.88 | 40 | 12709 | 21754 | 63454519 |
| Maternal exposure before pregnancy | 52.12 | 17.88 | 27 | 12722 | 7576 | 63468697 |
| Ear pain | 50.03 | 17.88 | 48 | 12701 | 36070 | 63440203 |
| Death | 49.43 | 17.88 | 8 | 12741 | 374373 | 63101900 |
| Poor quality product administered | 46.26 | 17.88 | 19 | 12730 | 3137 | 63473136 |
| Menstrual disorder | 45.66 | 17.88 | 22 | 12727 | 5291 | 63470982 |
| Transverse sinus thrombosis | 44.20 | 17.88 | 12 | 12737 | 546 | 63475727 |
| Smear cervix abnormal | 44.08 | 17.88 | 18 | 12731 | 2928 | 63473345 |
| Respiratory disorder | 43.25 | 17.88 | 46 | 12703 | 39036 | 63437237 |
| Cerebral thrombosis | 42.17 | 17.88 | 15 | 12734 | 1676 | 63474597 |
| Vena cava filter insertion | 42.10 | 17.88 | 9 | 12740 | 145 | 63476128 |
| Product storage error | 39.79 | 17.88 | 29 | 12720 | 14927 | 63461346 |
| Migraine | 39.68 | 17.88 | 73 | 12676 | 103273 | 63373000 |
| Body temperature increased | 36.33 | 17.88 | 41 | 12708 | 37151 | 63439122 |
| Toxic shock syndrome | 35.10 | 17.88 | 11 | 12738 | 831 | 63475442 |
| Post thrombotic syndrome | 34.70 | 17.88 | 10 | 12739 | 567 | 63475706 |
| Fall | 34.36 | 17.88 | 18 | 12731 | 392316 | 63083957 |
| Dyspareunia | 33.35 | 17.88 | 14 | 12735 | 2441 | 63473832 |
| Exposure during pregnancy | 32.46 | 17.88 | 86 | 12663 | 155461 | 63320812 |
| Complication associated with device | 32.30 | 17.88 | 27 | 12722 | 16951 | 63459322 |
| Papilloma viral infection | 31.99 | 17.88 | 12 | 12737 | 1558 | 63474715 |
| Hypomenorrhoea | 30.37 | 17.88 | 9 | 12740 | 563 | 63475710 |
| Cerebral venous thrombosis | 28.75 | 17.88 | 12 | 12737 | 2062 | 63474211 |
| Lower respiratory tract infection | 28.46 | 17.88 | 74 | 12675 | 132233 | 63344040 |
| Ovarian atrophy | 28.28 | 17.88 | 6 | 12743 | 93 | 63476180 |
| Irritable bowel syndrome | 27.66 | 17.88 | 55 | 12694 | 82357 | 63393916 |
| Muscle injury | 27.42 | 17.88 | 48 | 12701 | 65297 | 63410976 |
| Cholecystitis chronic | 27.36 | 17.88 | 20 | 12729 | 10341 | 63465932 |
| Uterine leiomyoma | 27.15 | 17.88 | 19 | 12730 | 9179 | 63467094 |
| Fungal infection | 26.80 | 17.88 | 35 | 12714 | 36839 | 63439434 |
| Pelvic pain | 26.76 | 17.88 | 22 | 12727 | 13497 | 63462776 |
| Abortion | 26.61 | 17.88 | 12 | 12737 | 2484 | 63473789 |
| Acute kidney injury | 26.31 | 17.88 | 10 | 12739 | 263405 | 63212868 |
| Folliculitis | 26.14 | 17.88 | 49 | 12700 | 70268 | 63406005 |
| Antiphospholipid antibodies positive | 25.57 | 17.88 | 8 | 12741 | 601 | 63475672 |
| Vulvovaginal burning sensation | 25.26 | 17.88 | 11 | 12738 | 2098 | 63474175 |
| Malaise | 25.05 | 17.88 | 28 | 12721 | 415926 | 63060347 |
| Product colour issue | 24.97 | 17.88 | 8 | 12741 | 649 | 63475624 |
| Coagulopathy | 24.19 | 17.88 | 25 | 12724 | 20519 | 63455754 |
| Pneumonia | 24.11 | 17.88 | 34 | 12715 | 456733 | 63019540 |
| Cerebrovascular accident | 23.82 | 17.88 | 61 | 12688 | 107963 | 63368310 |
| Superior sagittal sinus thrombosis | 23.52 | 17.88 | 8 | 12741 | 783 | 63475490 |
| Bacterial vulvovaginitis | 23.47 | 17.88 | 8 | 12741 | 788 | 63475485 |
| Unresponsive to stimuli | 22.89 | 17.88 | 31 | 12718 | 33785 | 63442488 |
| Vulvovaginal pain | 22.52 | 17.88 | 11 | 12738 | 2724 | 63473549 |
| Neutropenia | 22.49 | 17.88 | 4 | 12745 | 175001 | 63301272 |
| Coital bleeding | 22.39 | 17.88 | 7 | 12742 | 525 | 63475748 |
| Ovarian cyst | 21.71 | 17.88 | 21 | 12728 | 15924 | 63460349 |
| Breast tenderness | 21.01 | 17.88 | 10 | 12739 | 2340 | 63473933 |
| Abortion missed | 20.70 | 17.88 | 9 | 12740 | 1710 | 63474563 |
| Thrombocytopenia | 20.44 | 17.88 | 3 | 12746 | 151154 | 63325119 |
| Chlamydial infection | 20.41 | 17.88 | 6 | 12743 | 365 | 63475908 |
| Premenstrual syndrome | 20.32 | 17.88 | 7 | 12742 | 712 | 63475561 |
| Decreased appetite | 19.85 | 17.88 | 13 | 12736 | 251039 | 63225234 |
| Venous stent insertion | 19.25 | 17.88 | 3 | 12746 | 6 | 63476267 |
| Depression | 19.01 | 17.88 | 84 | 12665 | 196408 | 63279865 |
| Vaginal infection | 18.70 | 17.88 | 14 | 12735 | 7504 | 63468769 |
| Cervicitis | 18.55 | 17.88 | 6 | 12743 | 502 | 63475771 |
| Cough | 18.39 | 17.88 | 19 | 12730 | 292724 | 63183549 |
| Sinusitis | 18.35 | 17.88 | 92 | 12657 | 226561 | 63249712 |
| Ectropion of cervix | 18.24 | 17.88 | 4 | 12745 | 73 | 63476200 |
| Drug level decreased | 18.05 | 17.88 | 14 | 12735 | 7905 | 63468368 |
| Hypotension | 17.92 | 17.88 | 17 | 12732 | 272587 | 63203686 |
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Pulmonary embolism | 532.23 | 22.63 | 298 | 8960 | 171356 | 79563774 |
| Intermenstrual bleeding | 481.03 | 22.63 | 116 | 9142 | 5768 | 79729362 |
| Unintended pregnancy | 477.95 | 22.63 | 107 | 9151 | 3826 | 79731304 |
| Device expulsion | 318.93 | 22.63 | 118 | 9140 | 25743 | 79709387 |
| Deep vein thrombosis | 244.54 | 22.63 | 160 | 9098 | 120759 | 79614371 |
| Incorrect product administration duration | 217.54 | 22.63 | 73 | 9185 | 11949 | 79723181 |
| Inappropriate schedule of product administration | 211.42 | 22.63 | 152 | 9106 | 133476 | 79601654 |
| Pregnancy with contraceptive device | 208.29 | 22.63 | 54 | 9204 | 3600 | 79731530 |
| Heavy menstrual bleeding | 140.43 | 22.63 | 55 | 9203 | 13956 | 79721174 |
| Medical device discomfort | 130.09 | 22.63 | 32 | 9226 | 1722 | 79733408 |
| Vulvovaginal discomfort | 108.81 | 22.63 | 28 | 9230 | 1810 | 79733320 |
| Abortion induced | 108.42 | 22.63 | 38 | 9220 | 7071 | 79728059 |
| Vaginal discharge | 95.39 | 22.63 | 35 | 9223 | 7428 | 79727702 |
| Product quality issue | 94.07 | 22.63 | 55 | 9203 | 33885 | 79701245 |
| Night sweats | 74.82 | 22.63 | 56 | 9202 | 52039 | 79683091 |
| Menstruation irregular | 73.29 | 22.63 | 26 | 9232 | 5010 | 79730120 |
| Muscle spasticity | 70.82 | 22.63 | 39 | 9219 | 21436 | 79713694 |
| Vulvovaginal mycotic infection | 68.07 | 22.63 | 24 | 9234 | 4542 | 79730588 |
| Ear pain | 67.48 | 22.63 | 44 | 9214 | 32825 | 79702305 |
| Menstruation delayed | 66.58 | 22.63 | 18 | 9240 | 1408 | 79733722 |
| Device failure | 64.21 | 22.63 | 25 | 9233 | 6236 | 79728894 |
| Abnormal withdrawal bleeding | 63.58 | 22.63 | 10 | 9248 | 45 | 79735085 |
| Cerebral venous sinus thrombosis | 62.39 | 22.63 | 19 | 9239 | 2272 | 79732858 |
| Vaginal haemorrhage | 59.50 | 22.63 | 35 | 9223 | 21782 | 79713348 |
| Withdrawal bleed | 57.68 | 22.63 | 9 | 9249 | 38 | 79735092 |
| Abortion spontaneous | 54.53 | 22.63 | 37 | 9221 | 29470 | 79705660 |
| Dysmenorrhoea | 53.11 | 22.63 | 18 | 9240 | 3027 | 79732103 |
| Respiratory disorder | 53.06 | 22.63 | 43 | 9215 | 44813 | 79690317 |
| No adverse event | 51.21 | 22.63 | 39 | 9219 | 37153 | 79697977 |
| Ectopic pregnancy | 49.80 | 22.63 | 15 | 9243 | 1728 | 79733402 |
| Hypercoagulation | 49.46 | 22.63 | 17 | 9241 | 2983 | 79732147 |
| Lower respiratory tract infection | 48.42 | 22.63 | 67 | 9191 | 129153 | 79605977 |
| Muscle injury | 48.05 | 22.63 | 42 | 9216 | 48519 | 79686611 |
| Body temperature increased | 47.16 | 22.63 | 40 | 9218 | 44380 | 79690750 |
| Cervical dysplasia | 46.63 | 22.63 | 15 | 9243 | 2146 | 79732984 |
| Folliculitis | 45.22 | 22.63 | 43 | 9215 | 55337 | 79679793 |
| Transverse sinus thrombosis | 43.64 | 22.63 | 11 | 9247 | 654 | 79734476 |
| Exposure during pregnancy | 43.33 | 22.63 | 56 | 9202 | 101076 | 79634054 |
| Acute kidney injury | 43.02 | 22.63 | 5 | 9253 | 519399 | 79215731 |
| Irritable bowel syndrome | 42.79 | 22.63 | 44 | 9214 | 62197 | 79672933 |
| Device breakage | 42.55 | 22.63 | 22 | 9236 | 10653 | 79724477 |
| Thrombosis | 39.89 | 22.63 | 49 | 9209 | 84051 | 79651079 |
| Menstrual disorder | 37.36 | 22.63 | 15 | 9243 | 4052 | 79731078 |
| Death | 37.10 | 22.63 | 10 | 9248 | 566504 | 79168626 |
| Migraine | 36.78 | 22.63 | 48 | 9210 | 87445 | 79647685 |
| Sinusitis | 36.30 | 22.63 | 74 | 9184 | 195427 | 79539703 |
| Amenorrhoea | 34.00 | 22.63 | 17 | 9241 | 7675 | 79727455 |
| Hypotension | 32.38 | 22.63 | 6 | 9252 | 440311 | 79294819 |
| Ovarian atrophy | 31.81 | 22.63 | 6 | 9252 | 89 | 79735041 |
| Fall | 31.18 | 22.63 | 9 | 9249 | 487620 | 79247510 |
| Cholecystitis chronic | 29.95 | 22.63 | 17 | 9241 | 9889 | 79725241 |
| Impaired healing | 29.20 | 22.63 | 43 | 9215 | 87612 | 79647518 |
| Cerebral venous thrombosis | 28.25 | 22.63 | 11 | 9247 | 2742 | 79732388 |
| Abortion missed | 28.07 | 22.63 | 9 | 9249 | 1274 | 79733856 |
| Blister | 28.05 | 22.63 | 50 | 9208 | 119426 | 79615704 |
| Complication associated with device | 27.79 | 22.63 | 20 | 9238 | 17476 | 79717654 |
| Uterine leiomyoma | 27.77 | 22.63 | 14 | 9244 | 6429 | 79728701 |
| Ill-defined disorder | 27.46 | 22.63 | 36 | 9222 | 65839 | 79669291 |
| Pneumonia | 27.35 | 22.63 | 22 | 9236 | 660224 | 79074906 |
| Sleep disorder due to general medical condition, insomnia type | 26.74 | 22.63 | 29 | 9229 | 43527 | 79691603 |
| Urticaria | 26.32 | 22.63 | 63 | 9195 | 185138 | 79549992 |
| Cerebral thrombosis | 26.14 | 22.63 | 10 | 9248 | 2377 | 79732753 |
| Pelvic pain | 25.24 | 22.63 | 17 | 9241 | 13364 | 79721766 |
| Pulmonary infarction | 24.69 | 22.63 | 11 | 9247 | 3838 | 79731292 |
| Ovarian failure | 24.52 | 22.63 | 7 | 9251 | 669 | 79734461 |
| Dyspareunia | 24.43 | 22.63 | 9 | 9249 | 1929 | 79733201 |
| Toxic shock syndrome | 24.23 | 22.63 | 8 | 9250 | 1241 | 79733889 |
| Contraindicated product administered | 23.92 | 22.63 | 55 | 9203 | 157483 | 79577647 |
| Neutropenia | 23.22 | 22.63 | 3 | 9255 | 287707 | 79447423 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | G03AA01 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations |
| ATC | G03AA02 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations |
| ATC | G03AA03 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations |
| ATC | G03AA04 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations |
| ATC | G03AA05 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations |
| ATC | G03AA06 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations |
| ATC | G03AA07 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations |
| ATC | G03AA08 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations |
| ATC | G03AA09 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations |
| ATC | G03AA10 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations |
| ATC | G03AA11 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations |
| ATC | G03AA12 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations |
| ATC | G03AA13 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations |
| ATC | G03AA15 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations |
| ATC | G03AA16 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations |
| ATC | G03AB01 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, sequential preparations |
| ATC | G03AB02 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, sequential preparations |
| ATC | G03AB03 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, sequential preparations |
| ATC | G03AB04 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, sequential preparations |
| ATC | G03AB05 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, sequential preparations |
| ATC | G03AB06 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, sequential preparations |
| ATC | G03AB07 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, sequential preparations |
| ATC | G03AB09 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, sequential preparations |
| ATC | G03CA01 | GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM ESTROGENS Natural and semisynthetic estrogens, plain |
| ATC | L02AA03 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ENDOCRINE THERAPY HORMONES AND RELATED AGENTS Estrogens |
| FDA MoA | N0000000100 | Estrogen Receptor Agonists |
| CHEBI has role | CHEBI:76988 | xenoestrogens |
| MeSH PA | D003270 | Contraceptive Agents |
| MeSH PA | D003271 | Contraceptive Agents, Female |
| MeSH PA | D000080066 | Contraceptive Agents, Hormonal |
| MeSH PA | D003278 | Contraceptives, Oral, Hormonal |
| MeSH PA | D004967 | Estrogens |
| MeSH PA | D006728 | Hormones |
| MeSH PA | D012102 | Reproductive Control Agents |
| FDA EPC | N0000175825 | Estrogen |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Premenstrual dysphoric disorder | indication | 596004 | |
| Contraception | indication | 13197004 | |
| Atrophic vaginitis | indication | 52441000 | |
| Acne vulgaris | indication | 88616000 | |
| Postmenopausal osteoporosis | indication | 102447009 | |
| Menopausal flushing | indication | 198436008 | |
| Atrophic vulva | indication | 248861000 | DOID:14275 |
| Dysmenorrhea | indication | 266599000 | |
| Controlled ovarian stimulation | indication | 732970000 | |
| Amenorrhea | off-label use | 14302001 | DOID:13938 |
| Female hypogonadism syndrome | off-label use | 16041008 | |
| Polycystic ovaries | off-label use | 69878008 | |
| Postcoital contraception | off-label use | 268463003 | |
| Abnormal uterine bleeding unrelated to menstrual cycle | off-label use | 312984006 | |
| Menorrhagia | off-label use | 386692008 | |
| Heart valve disorder | contraindication | 368009 | DOID:4079 |
| Hyperlipoproteinemia | contraindication | 3744001 | DOID:1168 |
| Hypocalcemia | contraindication | 5291005 | |
| Hypercholesterolemia | contraindication | 13644009 | |
| Hyperkalemia | contraindication | 14140009 | |
| Jaundice | contraindication | 18165001 | |
| Myocardial infarction | contraindication | 22298006 | DOID:5844 |
| Diplopia | contraindication | 24982008 | |
| Retinal hemorrhage | contraindication | 28998008 | |
| Depressive disorder | contraindication | 35489007 | |
| Chloasma | contraindication | 36209000 | |
| Migraine | contraindication | 37796009 | DOID:6364 |
| Hypertensive disorder | contraindication | 38341003 | DOID:10763 |
| Disorder of gallbladder | contraindication | 39621005 | DOID:0060262 |
| Hypothyroidism | contraindication | 40930008 | DOID:1459 |
| Body fluid retention | contraindication | 43498006 | |
| Thrombosis of retinal vein | contraindication | 46085004 | |
| Humoral hypercalcemia of malignancy | contraindication | 47709007 | |
| Chronic heart failure | contraindication | 48447003 | |
| Dementia | contraindication | 52448006 | |
| Hepatic porphyria | contraindication | 55056006 | DOID:3133 |
| Systemic lupus erythematosus | contraindication | 55464009 | DOID:9074 |
| Hyperlipidemia | contraindication | 55822004 | DOID:1168 |
| Benign mammary dysplasia | contraindication | 57993004 | |
| Acute nephropathy | contraindication | 58574008 | |
| Obstructive hyperbilirubinemia | contraindication | 59848001 | |
| Thrombophlebitis | contraindication | 64156001 | DOID:3875 |
| Intermenstrual bleeding - irregular | contraindication | 64996003 | |
| Hypercalcemia | contraindication | 66931009 | DOID:12678 |
| Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
| Hyperglycemia | contraindication | 80394007 | DOID:4195 |
| Heart failure | contraindication | 84114007 | DOID:6000 |
| Epilepsy | contraindication | 84757009 | DOID:1826 |
| Breast lump | contraindication | 89164003 | |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Malignant neoplasm of liver | contraindication | 93870000 | DOID:3571 |
| Uterine leiomyoma | contraindication | 95315005 | DOID:13223 |
| Neoplasm of prostate | contraindication | 126906006 | DOID:10283 |
| Deep venous thrombosis | contraindication | 128053003 | |
| Seizure disorder | contraindication | 128613002 | |
| Endometriosis | contraindication | 129103003 | |
| Bed-ridden | contraindication | 160685001 | |
| Liver function tests abnormal | contraindication | 166603001 | |
| Mammography abnormal | contraindication | 168750009 | |
| Angina pectoris | contraindication | 194828000 | |
| Asthma | contraindication | 195967001 | DOID:2841 |
| Cerebrovascular accident | contraindication | 230690007 | |
| Pulmonary thromboembolism | contraindication | 233935004 | |
| Thrombophilia | contraindication | 234467004 | DOID:2452 |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Cholestasis of pregnancy | contraindication | 235888006 | |
| Endometrial carcinoma | contraindication | 254878006 | DOID:2871 |
| Benign prostatic hyperplasia | contraindication | 266569009 | |
| Edema | contraindication | 267038008 | |
| Chorea | contraindication | 271700006 | |
| Pregnancy, function | contraindication | 289908002 | |
| Hypertriglyceridemia | contraindication | 302870006 | |
| Functional visual loss | contraindication | 313165001 | |
| Malignant tumor of cervix | contraindication | 363354003 | DOID:4362 |
| Malignant tumor of ovary | contraindication | 363443007 | DOID:2394 |
| Thromboembolic disorder | contraindication | 371039008 | |
| Adrenal cortical hypofunction | contraindication | 386584007 | DOID:10493 |
| Cardiovascular event risk | contraindication | 395112001 | |
| Breastfeeding (mother) | contraindication | 413712001 | |
| Disorder of coronary artery | contraindication | 414024009 | |
| Obesity | contraindication | 414916001 | DOID:9970 |
| Estrogen receptor positive tumor | contraindication | 416053008 | |
| Porphyria | contraindication | 418470004 | |
| Optic disc edema | contraindication | 423341008 | DOID:146 |
| Family history of malignant neoplasm of breast | contraindication | 429740004 | |
| Hypertensive urgency | contraindication | 443482000 | |
| Carcinoma of female breast | contraindication | 447782002 | |
| Smokes tobacco daily | contraindication | 449868002 | |
| Nonspecific Abnormal Papanicolaou Smear of Cervix | contraindication | ||
| Breast Carcinoma in Males | contraindication | ||
| Major Surgery with Prolonged Post-Operative Immobilization | contraindication | ||
| Diabetes with Vascular Disease Complication | contraindication | ||
| Benign Hepatic Cell Adenoma | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 11.13 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.03MG,0.01MG;0.15MG,N/A | SEASONIQUE | TEVA BRANDED PHARM | N021840 | May 25, 2006 | RX | TABLET | ORAL | 7615545 | June 15, 2023 | PREVENTION OF PREGNANCY |
| 0.02MG,0.1MG;0.01MG,N/A | LOSEASONIQUE | TEVA BRANDED PHARM | N022262 | Oct. 24, 2008 | RX | TABLET | ORAL | 7615545 | June 15, 2023 | PREVENTION OF PREGNANCY |
| 0.03MG,0.01MG;0.15MG,N/A | SEASONIQUE | TEVA BRANDED PHARM | N021840 | May 25, 2006 | RX | TABLET | ORAL | 7320969 | Jan. 30, 2024 | PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOD OF CONTRACEPTION |
| 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A | QUARTETTE | TEVA BRANDED PHARM | N204061 | March 28, 2013 | RX | TABLET | ORAL | 8450299 | Oct. 7, 2025 | PREVENTION OF PREGNANCY |
| 0.02MG;0.1MG | BALCOLTRA | AVION PHARMS | N208612 | Jan. 9, 2018 | RX | TABLET | ORAL | 7838042 | June 1, 2027 | ADMINISTRATION OF FERROUS BISGLYCINATE TABLETS |
| 0.03MG,0.01MG;0.15MG,N/A | SEASONIQUE | TEVA BRANDED PHARM | N021840 | May 25, 2006 | RX | TABLET | ORAL | 7855190 | Dec. 5, 2028 | PREVENTION OF PREGNANCY |
| 0.02MG,0.1MG;0.01MG,N/A | LOSEASONIQUE | TEVA BRANDED PHARM | N022262 | Oct. 24, 2008 | RX | TABLET | ORAL | 7855190 | Dec. 5, 2028 | PREVENTION OF PREGNANCY |
| 0.01MG,0.01MG;1MG,N/A | LO LOESTRIN FE | APIL | N022501 | Oct. 21, 2010 | RX | TABLET | ORAL | 7704984 | Feb. 2, 2029 | LO LOESTRIN FE IS INDICATED FOR THE PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOD OF CONTRACEPTION |
| 0.01MG,0.01MG,N/A;1MG,N/A,N/A | LO MINASTRIN FE | APIL | N204654 | July 24, 2013 | DISCN | TABLET, CHEWABLE, TABLET | ORAL | 7704984 | Feb. 2, 2029 | PREVENTION OF PREGNANCY |
| 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG | BEYAZ | BAYER HLTHCARE | N022532 | Sept. 24, 2010 | RX | TABLET | ORAL | 11617751 | July 17, 2030 | PREVENTION OF PREGNANCY |
| 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG | BEYAZ | BAYER HLTHCARE | N022532 | Sept. 24, 2010 | RX | TABLET | ORAL | 11617751 | July 17, 2030 | RAISE FOLATE LEVELS IN WOMEN WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION FOR THE PURPOSE OF REDUCING THE RISK OF A NEURAL TUBE DEFECT IN A PREGNANCY |
| 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG | BEYAZ | BAYER HLTHCARE | N022532 | Sept. 24, 2010 | RX | TABLET | ORAL | 11617751 | July 17, 2030 | TREATMENT OF MODERATE ACNE VULGARIS IN WOMEN AT LEAST 14 YEARS OF AGE IF THE PATIENT DESIRES AN ORAL CONTRACEPTIVE FOR BIRTH CONTROL |
| 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG | BEYAZ | BAYER HLTHCARE | N022532 | Sept. 24, 2010 | RX | TABLET | ORAL | 11617751 | July 17, 2030 | TREATMENT OF MOOD CHANGES AND/OR ANXIETY AS SYMPTOMS OF PREMENSTRUAL DYSPHORIC DISORDER (PMDD) IN WOMEN WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION |
| 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG | SAFYRAL | BAYER HLTHCARE | N022574 | Dec. 16, 2010 | RX | TABLET | ORAL | 11617751 | July 17, 2030 | PREVENTION OF PREGNANCY |
| 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG | SAFYRAL | BAYER HLTHCARE | N022574 | Dec. 16, 2010 | RX | TABLET | ORAL | 11617751 | July 17, 2030 | RAISE FOLATE LEVELS IN WOMEN WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION FOR THE PURPOSE OF REDUCING THE RISK OF A NEURAL TUBE DEFECT IN A PREGNANCY |
| 0.013MG/24HR;0.15MG/24HR | ANNOVERA | MAYNE PHARMA | N209627 | Aug. 10, 2018 | RX | RING | VAGINAL | 10632066 | Feb. 1, 2039 | METHOD OF CONTRACEPTION BY INSERTING A VAGINAL SYSTEM FOR UP TO 13 21/7-DAY (IN/OUT) CYCLES, WHEREIN EFFICACY REQUIRES THE SYSTEM CANNOT BE OUT OF THE VAGINA FOR MORE THAN 2 CUMULATIVE HOURS IN ANY SUCH CYCLE WITHOUT USING ALTERNATIVE CONTRACEPTION |
| 0.013MG/24HR;0.15MG/24HR | ANNOVERA | MAYNE PHARMA | N209627 | Aug. 10, 2018 | RX | RING | VAGINAL | 10632066 | Feb. 1, 2039 | METHOD OF PREVENTING PREGNANCY BY INSERTING A VAGINAL SYSTEM CONTAINING 103 MG OF SEGESTERONE ACETATE AND 17.4 MG ETHINYL ESTRADIOL INTO A VAGINA FOR UP TO THIRTEEN 21/7-DAY (IN/OUT) CYCLES |
| 0.013MG/24HR;0.15MG/24HR | ANNOVERA | MAYNE PHARMA | N209627 | Aug. 10, 2018 | RX | RING | VAGINAL | 10765628 | Feb. 1, 2039 | METHOD OF CONTRACEPTION BY INSERTING A VAGINAL SYSTEM FOR UP TO 13 21/7-DAY (IN/OUT) CYCLES, WHEREIN EFFICACY REQUIRES THE SYSTEM CANNOT BE OUT OF THE VAGINA FOR MORE THAN 2 CUMULATIVE HOURS IN ANY SUCH CYCLE WITHOUT USING ALTERNATIVE CONTRACEPTION |
| 0.013MG/24HR;0.15MG/24HR | ANNOVERA | MAYNE PHARMA | N209627 | Aug. 10, 2018 | RX | RING | VAGINAL | 10765628 | Feb. 1, 2039 | METHOD OF PREVENTING PREGNANCY BY INSERTING A VAGINAL SYSTEM CONTAINING 103 MG OF SEGESTERONE ACETATE AND 17.4 MG ETHINYL ESTRADIOL INTO A VAGINA FOR UP TO THIRTEEN 21/7-DAY (IN/OUT) CYCLES |
| 0.013MG/24HR;0.15MG/24HR | ANNOVERA | MAYNE PHARMA | N209627 | Aug. 10, 2018 | RX | RING | VAGINAL | 10780047 | Feb. 1, 2039 | METHOD OF CONTRACEPTION BY INSERTING A VAGINAL SYSTEM FOR UP TO 13 21/7-DAY (IN/OUT) CYCLES, WHEREIN EFFICACY REQUIRES THE SYSTEM CANNOT BE OUT OF THE VAGINA FOR MORE THAN 2 CUMULATIVE HOURS IN ANY SUCH CYCLE WITHOUT USING ALTERNATIVE CONTRACEPTION |
| 0.013MG/24HR;0.15MG/24HR | ANNOVERA | MAYNE PHARMA | N209627 | Aug. 10, 2018 | RX | RING | VAGINAL | 10780047 | Feb. 1, 2039 | METHOD OF PREVENTING PREGNANCY BY INSERTING A VAGINAL SYSTEM CONTAINING 103 MG OF SEGESTERONE ACETATE AND 17.4 MG ETHINYL ESTRADIOL INTO A VAGINA FOR UP TO THIRTEEN 21/7-DAY (IN/OUT) CYCLES |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 0.03MG/24HR;0.12MG/24HR | TWIRLA | AGILE | N204017 | Feb. 14, 2020 | RX | SYSTEM | TRANSDERMAL | Feb. 14, 2023 | NEW PRODUCT |
| 0.02MG;0.1MG | TYBLUME | EXELTIS USA INC | N209405 | March 30, 2020 | RX | TABLET | ORAL | March 30, 2023 | NEW DOSAGE FORM |
| 0.013MG/24HR;0.15MG/24HR | ANNOVERA | MAYNE PHARMA | N209627 | Aug. 10, 2018 | RX | RING | VAGINAL | Aug. 10, 2023 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Estrogen receptor | Nuclear hormone receptor | AGONIST | Kd | 9.83 | WOMBAT-PK | CHEMBL | |||
| Nuclear receptor subfamily 1 group I member 3 | Nuclear hormone receptor | IC50 | 5.52 | CHEMBL | |||||
| Mu-type opioid receptor | GPCR | Ki | 4.96 | DRUG MATRIX | |||||
| Adenosine receptor A2a | GPCR | Ki | 4.93 | DRUG MATRIX | |||||
| Sodium-dependent serotonin transporter | Transporter | Ki | 7.54 | DRUG MATRIX | |||||
| Sodium-dependent noradrenaline transporter | Transporter | Ki | 6.02 | DRUG MATRIX | |||||
| Aldehyde oxidase | Enzyme | IC50 | 6.24 | WOMBAT-PK | |||||
| Glucocorticoid receptor | Nuclear hormone receptor | Ki | 6.11 | DRUG MATRIX | |||||
| Sodium-dependent dopamine transporter | Transporter | Ki | 6.35 | DRUG MATRIX | |||||
| Adenosine receptor A3 | GPCR | Ki | 4.73 | DRUG MATRIX | |||||
| Kappa-type opioid receptor | GPCR | Ki | 4.99 | DRUG MATRIX | |||||
| Androgen receptor | Nuclear hormone receptor | IC50 | 7.30 | WOMBAT-PK | |||||
| Estrogen receptor beta | Nuclear hormone receptor | IC50 | 8.09 | CHEMBL | |||||
| Sex hormone-binding globulin | Secreted | Kd | 6.81 | CHEMBL | |||||
| Solute carrier family 22 member 2 | Transporter | IC50 | 5.66 | CHEMBL | |||||
| Multidrug and toxin extrusion protein 1 | Transporter | IC50 | 4.68 | CHEMBL | |||||
| Multidrug and toxin extrusion protein 2 | Transporter | IC50 | 4.69 | CHEMBL | |||||
| Proton-coupled amino acid transporter 1 | Transporter | INHIBITOR | IC50 | 4.60 | IUPHAR | ||||
| Androgen receptor | Transcription factor | IC50 | 5.09 | CHEMBL | |||||
| Arachidonate 15-lipoxygenase | Enzyme | IC50 | 5.25 | DRUG MATRIX | |||||
| Progesterone receptor | Transcription factor | Ki | 6.86 | DRUG MATRIX | |||||
| 5-hydroxytryptamine receptor 4 | GPCR | Ki | 5.88 | DRUG MATRIX |
External reference:
| ID | Source |
|---|---|
| 423D2T571U | UNII |
| 4018022 | VUID |
| N0000146366 | NUI |
| D00554 | KEGG_DRUG |
| 4018022 | VANDF |
| C0015011 | UMLSCUI |
| CHEBI:4903 | CHEBI |
| 3WF | PDB_CHEM_ID |
| CHEMBL691 | ChEMBL_ID |
| 5991 | PUBCHEM_CID |
| DB00977 | DRUGBANK_ID |
| D004997 | MESH_DESCRIPTOR_UI |
| 437 | INN_ID |
| 7071 | IUPHAR_LIGAND_ID |
| 4124 | RXNORM |
| 4698 | MMSL |
| 72166 | MMSL |
| d00229 | MMSL |
| 001286 | NDDF |
| 126097006 | SNOMEDCT_US |
| 15432003 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| NuvaRing | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0052-0273 | INSERT, EXTENDED RELEASE | 0.02 mg | VAGINAL | NDA | 28 sections |
| Jinteli | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0093-3122 | TABLET | 5 ug | ORAL | ANDA | 29 sections |
| Etonogestrel and Ethinyl Estradiol | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0093-7679 | INSERT, EXTENDED RELEASE | 0.02 mg | VAGINAL | ANDA | 29 sections |
| Etonogestrel and Ethinyl Estradiol | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0093-7679 | INSERT, EXTENDED RELEASE | 0.02 mg | VAGINAL | ANDA | 29 sections |
| XULANE | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0378-3340 | PATCH | 35 ug | TRANSDERMAL | ANDA | 28 sections |
| XULANE | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0378-3340 | PATCH | 35 ug | TRANSDERMAL | ANDA | 28 sections |
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0378-7274 | TABLET | 0.03 mg | ORAL | ANDA | 15 sections |
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0378-7274 | TABLET | 0.03 mg | ORAL | ANDA | 15 sections |
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0378-7280 | TABLET | 0.02 mg | ORAL | ANDA | 15 sections |
| femhrt | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0430-0145 | TABLET | 2.50 ug | ORAL | NDA | 33 sections |
| Amethyst | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0480-3472 | TABLET | 20 ug | ORAL | ANDA | 24 sections |
| Amethyst | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0480-3472 | TABLET | 20 ug | ORAL | ANDA | 24 sections |
| Nortrel21 Day | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0555-9009 | TABLET | 0.04 mg | ORAL | ANDA | 21 sections |
| Nortrel21 Day | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0555-9009 | TABLET | 0.04 mg | ORAL | ANDA | 21 sections |
| Junel21 Day | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0555-9025 | TABLET | 20 ug | ORAL | ANDA | 15 sections |
| Junel21 Day | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0555-9025 | TABLET | 20 ug | ORAL | ANDA | 15 sections |
| Junel21 Day | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0555-9025 | TABLET | 20 ug | ORAL | ANDA | 15 sections |
| Junel21 Day | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0555-9027 | TABLET | 30 ug | ORAL | ANDA | 15 sections |
| Junel21 Day | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0555-9027 | TABLET | 30 ug | ORAL | ANDA | 15 sections |
| Junel21 Day | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0555-9027 | TABLET | 30 ug | ORAL | ANDA | 15 sections |
| Levonorgestrel and Ethinyl Estradiol | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0591-0295 | TABLET | 20 ug | ORAL | ANDA | 24 sections |
| ZAFEMY | HUMAN PRESCRIPTION DRUG LABEL | 2 | 42291-930 | PATCH | 35 ug | TRANSDERMAL | ANDA | 31 sections |
| NUVARING | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50090-1008 | INSERT, EXTENDED RELEASE | 0.02 mg | VAGINAL | NDA | 27 sections |
| XULANE | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50090-1683 | PATCH | 35 ug | TRANSDERMAL | ANDA | 29 sections |
| XULANE | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50090-1683 | PATCH | 35 ug | TRANSDERMAL | ANDA | 29 sections |
| NUVARING | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50090-5611 | INSERT, EXTENDED RELEASE | 0.02 mg | VAGINAL | NDA | 28 sections |
| NUVARING | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50090-5611 | INSERT, EXTENDED RELEASE | 0.02 mg | VAGINAL | NDA | 28 sections |
| Etonogestrel/Ethinyl Estradiol | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50090-5959 | INSERT, EXTENDED RELEASE | 0.02 mg | VAGINAL | NDA AUTHORIZED GENERIC | 29 sections |
| ANNOVERA | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50261-313 | RING | 17.40 mg | VAGINAL | NDA | 32 sections |
| ANNOVERA | HUMAN PRESCRIPTION DRUG LABEL | 2 | 50261-313 | RING | 17.40 mg | VAGINAL | NDA | 32 sections |