ethinylestradiol ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
estrogens 1082 57-63-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ethinylestradiol betadex
  • ethynyl estradiol
  • ethinylestradiol
  • ethinyl estradiol
  • 17-ethinylestradiol
  • ethinyloestradiol
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.
  • Molecular weight: 296.41
  • Formula: C20H24O2
  • CLOGP: 3.68
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 2
  • TPSA: 40.46
  • ALOGS: -4.64
  • ROTB: 0

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
25 mcg O
1.50 mg O

ADMET properties:

PropertyValueReference
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 ยตM/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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 3.751 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.398 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 44.875 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 26.730 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 1.410 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 3.460 % High 1
herg hERG pIC50 4.807 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 37.670 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 12.823 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 1.170 % High 1
kinase-safety-class ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,ITK,JAK3,MAP2K6,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PRKDC,STK33,TEK,TGFBR1,ZAP70 28
kinase-selectivity-class GRK2,MAP2K6 2
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.042 High 1
mh-clint Mouse hepatocyte intrinsic clearance 106.170 High 1
mppb Mouse plasma protein binding (% unbound) 1.930 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 2.698 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
pppb Pig plasma protein binding (% unbound) 2.850 % High 1
rh-clint Rat hepatocyte intrinsic clearance 107.152 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 16.990 % High 1
rppb Rat plasma protein binding (% unbound) 2.160 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 11.695 uM High 1

Approvals:

DateAgencyCompanyOrphan
June 25, 1943 FDA SCHERING
July 23, 2010 PMDA Bayer Yakuhin

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pulmonary embolism 788.89 16.69 440 19695 130380 90477932
Unintended pregnancy 624.85 16.69 172 19963 7465 90600847
Intermenstrual bleeding 548.66 16.69 162 19973 9061 90599251
Device expulsion 428.36 16.69 200 19935 40686 90567626
Deep vein thrombosis 406.28 16.69 253 19882 91367 90516945
Pregnancy with contraceptive device 262.38 16.69 80 20055 4986 90603326
Inappropriate schedule of product administration 250.63 16.69 231 19904 149702 90458610
Incorrect product administration duration 238.44 16.69 106 20029 19216 90589096
No adverse event 238.01 16.69 162 19973 67820 90540492
Medical device discomfort 164.93 16.69 46 20089 2090 90606222
Heavy menstrual bleeding 136.88 16.69 74 20061 20456 90587856
Product quality issue 133.88 16.69 123 20012 79202 90529110
Vulvovaginal discomfort 132.90 16.69 41 20094 2656 90605656
Abortion induced 102.69 16.69 51 20084 11837 90596475
Abnormal withdrawal bleeding 95.23 16.69 16 20119 53 90608259
Vaginal discharge 86.72 16.69 54 20081 19410 90588902
Cerebral venous sinus thrombosis 79.78 16.69 27 20108 2349 90605963
Hypercoagulation 77.35 16.69 26 20109 2216 90606096
Device breakage 72.96 16.69 43 20092 14001 90594311
Device failure 72.94 16.69 34 20101 6863 90601449
Night sweats 69.64 16.69 112 20023 128654 90479658
Vulvovaginal mycotic infection 69.50 16.69 32 20103 6282 90602030
Product shape issue 69.10 16.69 13 20122 93 90608219
Withdrawal bleed 66.20 16.69 12 20123 68 90608244
Thrombosis 65.37 16.69 81 20054 73170 90535142
Menstruation irregular 64.97 16.69 33 20102 8027 90600285
Ectopic pregnancy 64.42 16.69 25 20110 3216 90605096
Death 64.02 16.69 12 20123 456539 90151773
Abortion spontaneous 61.99 16.69 68 20067 53988 90554324
Cervical dysplasia 59.12 16.69 25 20110 4009 90604303
Dysmenorrhoea 58.80 16.69 26 20109 4646 90603666
Pulmonary infarction 56.39 16.69 22 20113 2870 90605442
Menstruation delayed 55.22 16.69 20 20115 2125 90606187
Vaginal haemorrhage 53.71 16.69 49 20086 31222 90577090
Amenorrhoea 45.94 16.69 30 20105 11692 90596620
Respiratory disorder 45.93 16.69 64 20071 64752 90543560
Fall 45.85 16.69 25 20110 481785 90126527
Lower respiratory tract infection 44.93 16.69 140 19995 250519 90357793
Ear pain 43.94 16.69 59 20076 57643 90550669
Blood oestrogen increased 43.04 16.69 10 20125 215 90608097
Transverse sinus thrombosis 41.81 16.69 12 20123 605 90607707
Smear cervix abnormal 41.20 16.69 18 20117 3124 90605188
Vena cava filter insertion 40.62 16.69 9 20126 155 90608157
Menstrual disorder 40.55 16.69 22 20113 6116 90602196
Poor quality product administered 40.05 16.69 19 20116 3989 90604323
Maternal exposure before pregnancy 39.85 16.69 27 20108 11186 90597126
Cerebral thrombosis 39.75 16.69 15 20120 1788 90606524
Acute kidney injury 39.73 16.69 11 20124 320376 90287936
Cerebral venous thrombosis 39.43 16.69 16 20119 2312 90606000
Sleep disorder due to general medical condition, insomnia type 35.19 16.69 84 20051 128610 90479702
Muscle spasticity 34.66 16.69 41 20094 35281 90573031
Neutropenia 33.51 16.69 5 20130 224899 90383413
Post thrombotic syndrome 33.48 16.69 10 20125 580 90607732
Drug ineffective 32.63 16.69 178 19957 1384120 89224192
Cough 32.47 16.69 21 20114 368941 90239371
Toxic shock syndrome 31.69 16.69 11 20124 1033 90607279
Folliculitis 31.09 16.69 108 20027 204245 90404067
Hypotension 30.76 16.69 17 20118 325380 90282932
Dyspareunia 30.29 16.69 14 20121 2772 90605540
Autoimmune disorder 30.10 16.69 58 20077 76686 90531626
Anaemia 29.81 16.69 21 20114 352781 90255531
Lupus vulgaris 29.71 16.69 43 20092 45016 90563296
Deep vein thrombosis postoperative 29.61 16.69 55 20080 70754 90537558
Product storage error 29.57 16.69 29 20106 20212 90588100
Lower limb fracture 29.45 16.69 61 20074 84952 90523360
Papilloma viral infection 29.34 16.69 12 20123 1770 90606542
Muscle injury 29.20 16.69 96 20039 176558 90431754
Drug level decreased 28.92 16.69 21 20114 9709 90598603
Cholecystitis chronic 28.73 16.69 21 20114 9805 90598507
Hypomenorrhoea 28.28 16.69 9 20126 645 90607667
Pneumonia 27.82 16.69 63 20072 637996 89970316
Ovarian atrophy 27.68 16.69 6 20129 93 90608219
Sinusitis 27.23 16.69 149 19986 342939 90265373
C-reactive protein 26.87 16.69 34 20101 31333 90576979
Complication associated with device 26.81 16.69 27 20108 19422 90588890
Migraine 25.88 16.69 97 20038 190295 90418017
Road traffic accident 24.97 16.69 66 20069 107560 90500752
Febrile neutropenia 24.82 16.69 3 20132 158346 90449966
Disease progression 24.47 16.69 3 20132 156612 90451700
Body temperature increased 24.29 16.69 39 20096 44671 90563641
Abortion 24.16 16.69 12 20123 2783 90605529
Antiphospholipid antibodies positive 24.02 16.69 8 20127 662 90607650
Haemoglobin decreased 23.22 16.69 4 20131 161952 90446360
Product colour issue 22.71 16.69 8 20127 784 90607528
Uterine leiomyoma 22.62 16.69 19 20116 10845 90597467
Superior sagittal sinus thrombosis 22.58 16.69 8 20127 798 90607514
Pelvic pain 22.42 16.69 22 20113 15335 90592977
Vulvovaginal burning sensation 22.01 16.69 11 20124 2584 90605728
Ovarian cyst 21.98 16.69 23 20112 17295 90591017
Bacterial vulvovaginitis 21.95 16.69 8 20127 865 90607447
Therapeutic product effect incomplete 21.64 16.69 8 20127 193888 90414424
Product dose omission issue 21.34 16.69 20 20115 291667 90316645
Thrombocytopenia 21.06 16.69 10 20125 208715 90399597
Irritable bowel syndrome 20.59 16.69 96 20039 207352 90400960
Fungal infection 20.22 16.69 35 20100 42626 90565686
White blood cell count decreased 20.22 16.69 6 20129 167103 90441209
Venous stent insertion 20.16 16.69 3 20132 3 90608309
Coital bleeding 20.07 16.69 7 20128 666 90607646
Atrial fibrillation 19.83 16.69 3 20132 133608 90474704
Chlamydial infection 19.83 16.69 6 20129 364 90607948
Pregnancy 19.72 16.69 43 20092 62004 90546308
Coagulopathy 19.56 16.69 25 20110 23264 90585048
Ill-defined disorder 19.42 16.69 87 20048 184804 90423508
Lupus-like syndrome 19.25 16.69 37 20098 48809 90559503
Breast tenderness 19.05 16.69 10 20125 2602 90605710
Vulvovaginal pain 19 16.69 11 20124 3463 90604849
Premenstrual syndrome 18.81 16.69 7 20128 803 90607509
Abortion missed 18.60 16.69 9 20126 1973 90606339
Somnolence 18.24 16.69 12 20123 209072 90399240
Fatigue 18.00 16.69 167 19968 1153856 89454456
Adjustment disorder with depressed mood 17.66 16.69 39 20096 56714 90551598
Ectropion of cervix 17.63 16.69 4 20131 77 90608235
Erythema 17.63 16.69 15 20120 229231 90379081
Impaired healing 17.42 16.69 100 20035 234099 90374213
Cervicitis 17.30 16.69 6 20129 562 90607750
Swollen joint count increased 17.09 16.69 59 20076 111147 90497165
Laryngitis 17.08 16.69 36 20099 50717 90557595
Peripheral venous disease 17.01 16.69 49 20086 83872 90524440
Liver injury 16.97 16.69 79 20056 170488 90437824

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Intermenstrual bleeding 433.78 21.41 116 16260 6818 110566105
Unintended pregnancy 430.40 21.41 107 16269 4701 110568222
Pulmonary embolism 419.01 21.41 305 16071 214169 110358754
Device expulsion 270.50 21.41 118 16258 30773 110542150
Deep vein thrombosis 192.52 21.41 162 16214 139725 110433198
Pregnancy with contraceptive device 191.62 21.41 54 16322 3853 110569070
Incorrect product administration duration 162.34 21.41 73 16303 20425 110552498
Inappropriate schedule of product administration 129.38 21.41 155 16221 203482 110369441
Heavy menstrual bleeding 119.23 21.41 55 16321 16310 110556613
Medical device discomfort 118.55 21.41 32 16344 1944 110570979
Vulvovaginal discomfort 98.03 21.41 28 16348 2096 110570827
Night sweats 96.78 21.41 109 16267 133874 110439049
Abortion induced 94.93 21.41 38 16338 7981 110564942
Lower respiratory tract infection 71.91 21.41 129 16247 242977 110329946
Acute kidney injury 71.82 21.41 6 16370 635424 109937499
Sleep disorder due to general medical condition, insomnia type 67.97 21.41 81 16295 105562 110467361
Death 65.89 21.41 12 16364 698857 109874066
Folliculitis 65.73 21.41 101 16275 167552 110405371
Menstruation irregular 63.56 21.41 26 16350 5771 110567152
Ear pain 61.76 21.41 56 16320 53170 110519753
Abnormal withdrawal bleeding 60.96 21.41 10 16366 46 110572877
Vulvovaginal mycotic infection 58.56 21.41 24 16352 5353 110567570
Respiratory disorder 58.34 21.41 62 16314 71320 110501603
Menstruation delayed 58.16 21.41 18 16358 1776 110571147
Vaginal discharge 57.99 21.41 35 16341 17873 110555050
Product quality issue 57.69 21.41 64 16312 77235 110495688
Muscle injury 56.84 21.41 86 16290 140721 110432202
Hypotension 56.37 21.41 6 16370 523843 110049080
Device failure 54.93 21.41 25 16351 7182 110565741
Lupus vulgaris 54.44 21.41 43 16333 33840 110539083
Cerebral venous sinus thrombosis 53.48 21.41 19 16357 2876 110570047
Withdrawal bleed 53.45 21.41 9 16367 50 110572873
Sinusitis 53.03 21.41 128 16248 296560 110276363
Lower limb fracture 50.49 21.41 59 16317 75289 110497634
Autoimmune disorder 50.22 21.41 55 16321 65428 110507495
Muscle spasticity 48.10 21.41 41 16335 35874 110537049
Blood oestrogen increased 47.77 21.41 10 16366 200 110572723
Vaginal haemorrhage 47.27 21.41 35 16341 25039 110547884
Fall 46.01 21.41 16 16360 603466 109969457
Dysmenorrhoea 45.84 21.41 18 16358 3592 110569331
Deep vein thrombosis postoperative 45.81 21.41 50 16326 59241 110513682
Hypercoagulation 43.71 21.41 17 16359 3309 110569614
Swollen joint count increased 42.45 21.41 57 16319 83604 110489319
Ill-defined disorder 42.26 21.41 80 16296 156773 110416150
Ectopic pregnancy 42.14 21.41 15 16361 2282 110570641
Abortion spontaneous 41.60 21.41 37 16339 34245 110538678
Neutropenia 41.04 21.41 4 16372 374616 110198307
Irritable bowel syndrome 40.88 21.41 81 16295 164134 110408789
Pemphigus 39.85 21.41 94 16282 214476 110358447
Psoriatic arthropathy 39.63 21.41 89 16287 196672 110376251
Cervical dysplasia 39.56 21.41 15 16361 2725 110570198
Transverse sinus thrombosis 39.27 21.41 11 16365 767 110572156
Impaired healing 38.53 21.41 88 16288 196629 110376294
Liver injury 37.21 21.41 74 16302 150339 110422584
Cerebral venous thrombosis 37.03 21.41 15 16361 3247 110569676
Lupus-like syndrome 36.13 21.41 37 16339 40755 110532168
Febrile neutropenia 35.72 21.41 3 16373 316764 110256159
Adjustment disorder with depressed mood 35.64 21.41 38 16338 43845 110529078
Pericarditis 35.40 21.41 91 16285 219023 110353900
C-reactive protein 35.35 21.41 32 16344 30299 110542624
Anaemia 34.58 21.41 19 16357 547067 110025856
Blister 33.25 21.41 91 16285 227285 110345638
Helicobacter infection 33.03 21.41 79 16297 181798 110391125
Device breakage 32.38 21.41 22 16354 13747 110559176
Pneumonia 32.31 21.41 50 16326 876664 109696259
Menstrual disorder 31.51 21.41 15 16361 4769 110568154
Laryngitis 31.43 21.41 35 16341 42376 110530547
Exostosis 30.80 21.41 36 16340 45920 110527003
Gastrointestinal disorder 30.69 21.41 92 16284 241860 110331063
Body temperature increased 30.42 21.41 39 16337 54674 110518249
Ovarian atrophy 30.35 21.41 6 16370 89 110572834
Duodenal ulcer perforation 29.94 21.41 75 16301 177625 110395298
Rheumatic fever 29.94 21.41 60 16316 122519 110450404
Sciatica 29.83 21.41 51 16325 92348 110480575
Anti-cyclic citrullinated peptide antibody positive 29.82 21.41 76 16300 181908 110391015
Urticaria 29.52 21.41 109 16267 318748 110254175
Migraine 29.50 21.41 73 16303 171579 110401344
Pregnancy 29.34 21.41 37 16339 51030 110521893
Product dose omission issue 29.27 21.41 6 16370 321776 110251147
Injury 29.02 21.41 74 16302 177191 110395732
Contusion 28.90 21.41 88 16288 233273 110339650
Bone erosion 28.90 21.41 35 16341 46336 110526587
Lip dry 28.14 21.41 52 16324 100031 110472892
Road traffic accident 27.96 21.41 54 16322 107344 110465579
Discomfort 27.56 21.41 82 16294 214625 110358298
X-ray abnormal 27.47 21.41 31 16345 38086 110534837
Amenorrhoea 27.23 21.41 17 16359 9214 110563709
Systemic lupus erythematosus 27.03 21.41 91 16285 254247 110318676
Cholecystitis chronic 26.78 21.41 17 16359 9483 110563440
Nasopharyngitis 26.41 21.41 122 16254 394239 110178684
Wound 25.91 21.41 85 16291 234352 110338571
Disease progression 25.70 21.41 3 16373 244031 110328892
No adverse event 25.49 21.41 42 16334 73797 110499126
Exposure during pregnancy 25.46 21.41 68 16308 167356 110405567
Thrombocytopenia 25.29 21.41 10 16366 348875 110224048
Peripheral venous disease 25.29 21.41 45 16331 84072 110488851
Prescribed overdose 25.24 21.41 46 16330 87535 110485388
Cough 25.11 21.41 19 16357 461622 110111301
Abdominal pain upper 24.86 21.41 110 16266 349001 110223922
Stomatitis 24.69 21.41 92 16284 270150 110302773
Abortion missed 24.33 21.41 9 16367 1528 110571395
Cerebral thrombosis 23.54 21.41 10 16366 2438 110570485
Infection 23.47 21.41 111 16265 362089 110210834
Constipation 23.21 21.41 12 16364 357774 110215149
Glossodynia 23.20 21.41 79 16297 221925 110350998
Sepsis 22.73 21.41 10 16366 327336 110245587
Drug level decreased 22.46 21.41 20 16356 18528 110554395
Hand deformity 22.18 21.41 77 16299 218429 110354494
Uterine leiomyoma 22.09 21.41 14 16362 7786 110565137
Dehydration 21.99 21.41 7 16369 279504 110293419
Off label use 21.69 21.41 132 16244 1500053 109072870

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
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
MeSH PA D000080066 Contraceptive Agents, Hormonal
MeSH PA D003271 Contraceptive Agents, Female
MeSH PA D003278 Contraceptives, Oral, Hormonal
MeSH PA D004967 Estrogens
MeSH PA D006728 Hormones
MeSH PA D012102 Reproductive Control Agents
FDA EPC N0000175825 Estrogen
CHEBI has role CHEBI:76988 xenoestrogens

Related Drugs by ATC class:

G03AA Progestogens and estrogens, fixed combinations 17 drugs
G03AB Progestogens and estrogens, sequential preparations 10 drugs
G03CA Natural and semisynthetic estrogens, plain 7 drugs
L02AA Estrogens 3 drugs

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.13 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
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
0.013MG/24HR;0.15MG/24HR ANNOVERA MAYNE PHARMA N209627 Aug. 10, 2018 RX RING VAGINAL 11850251 June 21, 2039 METHOD OF PREVENTING PREGNANCY BY INSERTING A VAGINAL SYSTEM CONTAINING 103 MG OF SEGESTERONE ACETATE AND 17.4 MG OF ETHINYL ESTRADIOL FOR UP TO 1THIRTEEN 21/7-DAY (IN/OUT) CYCLES

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.02MG;1MG FEMLYV MILLICENT MFG PR N218718 July 22, 2024 RX TABLET, ORALLY DISINTEGRATING ORAL July 22, 2027 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA 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:

IDSource
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
423D2T571U INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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
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 21 sections
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL HUMAN PRESCRIPTION DRUG LABEL 2 0378-7280 TABLET 0.02 mg ORAL ANDA 22 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
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
Etonogestrel and Ethinyl Estradiol Vaginal Ring HUMAN PRESCRIPTION DRUG LABEL 2 16714-029 RING 0.02 mg VAGINAL ANDA 22 sections
Etonogestrel and Ethinyl Estradiol Vaginal HUMAN PRESCRIPTION DRUG LABEL 2 42291-478 RING 0.02 mg VAGINAL ANDA 21 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 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
Norethindrone Acetate and Ethinyl Estradiol HUMAN PRESCRIPTION DRUG LABEL 2 50090-6782 TABLET 0.02 mg ORAL ANDA 16 sections
NUVARING HUMAN PRESCRIPTION DRUG LABEL 2 50090-7663 INSERT, EXTENDED RELEASE 0.02 mg VAGINAL NDA 28 sections
Dolishale HUMAN PRESCRIPTION DRUG LABEL 2 50742-659 TABLET 20 ug ORAL ANDA 15 sections
Loestrin21 Day HUMAN PRESCRIPTION DRUG LABEL 2 51285-127 TABLET 30 ug ORAL ANDA 15 sections
Loestrin21 Day HUMAN PRESCRIPTION DRUG LABEL 2 51285-131 TABLET 20 ug ORAL ANDA 15 sections
MICROGESTIN 1/20 HUMAN PRESCRIPTION DRUG LABEL 2 53002-1549 TABLET 20 ug ORAL NDA AUTHORIZED GENERIC 21 sections
femhrt HUMAN PRESCRIPTION DRUG LABEL 2 54868-4679 TABLET 5 ug ORAL NDA 20 sections
NuvaRing HUMAN PRESCRIPTION DRUG LABEL 2 54868-4832 INSERT, EXTENDED RELEASE 2.70 mg VAGINAL NDA 25 sections
Microgestin HUMAN PRESCRIPTION DRUG LABEL 2 54868-6213 TABLET 0.02 mg ORAL ANDA 24 sections
JINTELI HUMAN PRESCRIPTION DRUG LABEL 2 54868-6251 TABLET 5 ug ORAL ANDA 25 sections
Junel 1.5/30 HUMAN PRESCRIPTION DRUG LABEL 2 54868-6272 TABLET 30 ug ORAL ANDA 23 sections
NuvaRing HUMAN PRESCRIPTION DRUG LABEL 2 59212-146 INSERT, EXTENDED RELEASE 0.02 mg VAGINAL NDA 29 sections
ZAFEMY HUMAN PRESCRIPTION DRUG LABEL 2 65162-358 PATCH 35 ug TRANSDERMAL ANDA 31 sections
EluRyng HUMAN PRESCRIPTION DRUG LABEL 2 65162-469 RING 0.02 mg VAGINAL ANDA 29 sections