oxybutynin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| spasmolytics with a papaverine-like action | 2028 | 5633-20-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Oxybutynin acts as a competitive antagonist of acetylcholine at post-ganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle. Oxybutynin is a racemic (50:50) mixture of R- and S-isomers. Antimuscarinic activity resides predominantly in the R-isomer. The R-isomer of oxybutynin shows greater selectivity for the M1 and M3 muscarinic subtypes (predominant in bladder detrusor muscle and parotid gland) compared to the M2 subtype (predominant in cardiac tissue).
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 15 | mg | O |
| 3.90 | mg | TD |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 0.80 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 0.50 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.93 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 6 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 0.85 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 5.10 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.00 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 7.20 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 16, 1975 | FDA |
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 |
|---|---|---|---|---|---|---|
| Drug ineffective | 267.95 | 32.67 | 123 | 837 | 101501 | 2255624 |
| Application site erythema | 252.43 | 32.67 | 46 | 914 | 1234 | 2355891 |
| Dry mouth | 209.77 | 32.67 | 55 | 905 | 8198 | 2348927 |
| Completed suicide | 202.98 | 32.67 | 66 | 894 | 20968 | 2336157 |
| Drug hypersensitivity | 155.06 | 32.67 | 67 | 893 | 46576 | 2310549 |
| Application site pruritus | 143.45 | 32.67 | 27 | 933 | 859 | 2356266 |
| Product adhesion issue | 140.13 | 32.67 | 28 | 932 | 1224 | 2355901 |
| Application site rash | 94.70 | 32.67 | 18 | 942 | 601 | 2356524 |
| Pruritus | 86.73 | 32.67 | 44 | 916 | 43296 | 2313829 |
| Confusional state | 77.21 | 32.67 | 34 | 926 | 24310 | 2332815 |
| Urinary retention | 76.56 | 32.67 | 21 | 939 | 3646 | 2353479 |
| Toxicity to various agents | 73.54 | 32.67 | 36 | 924 | 32718 | 2324407 |
| Cardio-respiratory arrest | 65.23 | 32.67 | 23 | 937 | 9123 | 2348002 |
| Hyponatraemia | 63.79 | 32.67 | 25 | 935 | 13300 | 2343825 |
| Fall | 61.24 | 32.67 | 36 | 924 | 47063 | 2310062 |
| Hallucination | 56.22 | 32.67 | 20 | 940 | 8128 | 2348997 |
| Constipation | 55.20 | 32.67 | 26 | 934 | 21603 | 2335522 |
| Skin irritation | 53.72 | 32.67 | 13 | 947 | 1372 | 2355753 |
| Pollakiuria | 53.61 | 32.67 | 16 | 944 | 3740 | 2353385 |
| Respiratory arrest | 53.60 | 32.67 | 18 | 942 | 6160 | 2350965 |
| Erythema | 51.47 | 32.67 | 26 | 934 | 25133 | 2331992 |
| Product administered at inappropriate site | 50.73 | 32.67 | 11 | 949 | 712 | 2356413 |
| Somnolence | 50.18 | 32.67 | 25 | 935 | 23460 | 2333665 |
| Application site irritation | 49.20 | 32.67 | 10 | 950 | 472 | 2356653 |
| Rash | 48.70 | 32.67 | 34 | 926 | 59524 | 2297601 |
| Hallucination, visual | 48.25 | 32.67 | 14 | 946 | 2965 | 2354160 |
| Therapeutic product effect decreased | 47.26 | 32.67 | 19 | 941 | 10770 | 2346355 |
| Application site vesicles | 44.48 | 32.67 | 9 | 951 | 415 | 2356710 |
| Product complaint | 42.45 | 32.67 | 14 | 946 | 4524 | 2352601 |
| Overdose | 41.93 | 32.67 | 21 | 939 | 19886 | 2337239 |
| Hypertension | 41.03 | 32.67 | 23 | 937 | 27338 | 2329787 |
| Product quality issue | 40.38 | 32.67 | 17 | 943 | 10812 | 2346313 |
| Poisoning | 40.17 | 32.67 | 12 | 948 | 2808 | 2354317 |
| Dizziness | 39.95 | 32.67 | 30 | 930 | 58635 | 2298490 |
| Cerebral atrophy | 38.56 | 32.67 | 9 | 951 | 812 | 2356313 |
| Vision blurred | 38.50 | 32.67 | 18 | 942 | 14650 | 2342475 |
| Urinary incontinence | 35.37 | 32.67 | 12 | 948 | 4221 | 2352904 |
| Porphyria acute | 35.30 | 32.67 | 6 | 954 | 104 | 2357021 |
| Cardiac arrest | 35.14 | 32.67 | 17 | 943 | 14913 | 2342212 |
FDA Adverse Event Reporting System (Male)
| 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 |
|---|---|---|---|---|---|---|
| Completed suicide | 245.10 | 38.66 | 70 | 463 | 16242 | 1730006 |
| Dry mouth | 167.98 | 38.66 | 39 | 494 | 3874 | 1742374 |
| Confusional state | 140.51 | 38.66 | 49 | 484 | 21229 | 1725019 |
| Urinary retention | 92.90 | 38.66 | 26 | 507 | 5369 | 1740879 |
| Constipation | 70.37 | 38.66 | 27 | 506 | 14973 | 1731275 |
| Toxicity to various agents | 59.09 | 38.66 | 29 | 504 | 29112 | 1717136 |
| Muscle spasticity | 54.31 | 38.66 | 13 | 520 | 1436 | 1744812 |
| Agitation | 45.06 | 38.66 | 18 | 515 | 11008 | 1735240 |
| Vision blurred | 42.38 | 38.66 | 16 | 517 | 8407 | 1737841 |
| Hepatitis acute | 40.55 | 38.66 | 10 | 523 | 1247 | 1745001 |
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | G04BD04 | GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS UROLOGICALS Drugs for urinary frequency and incontinence |
| MeSH PA | D018678 | Cholinergic Agents |
| MeSH PA | D018680 | Cholinergic Antagonists |
| MeSH PA | D018727 | Muscarinic Antagonists |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D010276 | Parasympatholytics |
| MeSH PA | D018373 | Peripheral Nervous System Agents |
| CHEBI has role | CHEBI:50370 | parasympatholytic |
| CHEBI has role | CHEBI:53784 | antispasmodic drug |
| CHEBI has role | CHEBI:51371 | muscle relaxant |
| CHEBI has role | CHEBI:36333 | local anaesthetic |
| CHEBI has role | CHEBI:48876 | muscarinic antagonist |
| FDA EPC | N0000175700 | Cholinergic Muscarinic Antagonist |
| FDA MoA | N0000000125 | Cholinergic Muscarinic Antagonists |
| MeSH PA | D064804 | Urological Agents |
Drug Use (View source of the data)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Urgent desire to urinate | indication | 75088002 | |
| Urge incontinence of urine | indication | 87557004 | |
| Bladder muscle dysfunction - overactive | indication | 236633002 | |
| Neurogenic bladder | indication | 398064005 | |
| Increased Urinary Frequency | indication | ||
| Sinus tachycardia | contraindication | 11092001 | |
| Severe chronic ulcerative colitis | contraindication | 14311001 | |
| Toxic megacolon | contraindication | 28536002 | DOID:1770 |
| Atony of colon | contraindication | 29479008 | |
| Hyperthyroidism | contraindication | 34486009 | DOID:7998 |
| Hypertensive disorder | contraindication | 38341003 | DOID:10763 |
| Conduction disorder of the heart | contraindication | 44808001 | |
| Chronic heart failure | contraindication | 48447003 | |
| Paralytic ileus | contraindication | 55525008 | DOID:8442 |
| Ulcerative colitis | contraindication | 64766004 | DOID:8577 |
| Hiatal hernia | contraindication | 84089009 | DOID:12642 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Myasthenia gravis | contraindication | 91637004 | DOID:437 |
| Gastrointestinal obstruction | contraindication | 126765001 | |
| Gastroesophageal reflux disease | contraindication | 235595009 | DOID:8534 |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Bladder outflow obstruction | contraindication | 236645006 | |
| Benign prostatic hyperplasia | contraindication | 266569009 | |
| Retention of urine | contraindication | 267064002 | |
| Drowsy | contraindication | 271782001 | |
| Gastric retention | contraindication | 307227006 | |
| Angle-closure glaucoma | contraindication | 392291006 | DOID:13550 |
| Disorder of coronary artery | contraindication | 414024009 | |
| Gastrointestinal hypomotility | contraindication | 421807004 |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 7.67 | Basic |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 3.9MG/24HR | OXYTROL | ALLERGAN | N021351 | Feb. 26, 2003 | RX | FILM, EXTENDED RELEASE | TRANSDERMAL | 6743441 | April 26, 2020 | TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE |
| 3.9MG/24HR | OXYTROL | ALLERGAN | N021351 | Feb. 26, 2003 | RX | FILM, EXTENDED RELEASE | TRANSDERMAL | 7081249 | April 26, 2020 | TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE |
| 3.9MG/24HR | OXYTROL | ALLERGAN | N021351 | Feb. 26, 2003 | RX | FILM, EXTENDED RELEASE | TRANSDERMAL | 7081250 | April 26, 2020 | TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE |
| 3.9MG/24HR | OXYTROL | ALLERGAN | N021351 | Feb. 26, 2003 | RX | FILM, EXTENDED RELEASE | TRANSDERMAL | 7081251 | April 26, 2020 | TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE |
| 3.9MG/24HR | OXYTROL | ALLERGAN | N021351 | Feb. 26, 2003 | RX | FILM, EXTENDED RELEASE | TRANSDERMAL | 7081252 | April 26, 2020 | TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE |
| 3.9MG/24HR | OXYTROL | ALLERGAN | N021351 | Feb. 26, 2003 | RX | FILM, EXTENDED RELEASE | TRANSDERMAL | 7179483 | April 26, 2020 | TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE |
| 10% (100MG/PACKET) | GELNIQUE | ALLERGAN | N022204 | Jan. 27, 2009 | RX | GEL | TRANSDERMAL | 10272061 | April 26, 2020 | TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY OR URGE INCONTINENCE |
| 10% (100MG/PACKET) | GELNIQUE | ALLERGAN | N022204 | Jan. 27, 2009 | RX | GEL | TRANSDERMAL | 7029694 | April 26, 2020 | TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE |
| 10% (100MG/PACKET) | GELNIQUE | ALLERGAN | N022204 | Jan. 27, 2009 | RX | GEL | TRANSDERMAL | 7179483 | April 26, 2020 | TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE |
| 10% (100MG/PACKET) | GELNIQUE | ALLERGAN | N022204 | Jan. 27, 2009 | RX | GEL | TRANSDERMAL | 8241662 | April 26, 2020 | TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE |
| 3.9MG/24HR | OXYTROL FOR WOMEN | ALLERGAN | N202211 | Jan. 25, 2013 | OTC | FILM, EXTENDED RELEASE | TRANSDERMAL | 6743441 | April 26, 2020 | TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER |
| 3.9MG/24HR | OXYTROL FOR WOMEN | ALLERGAN | N202211 | Jan. 25, 2013 | OTC | FILM, EXTENDED RELEASE | TRANSDERMAL | 7081249 | April 26, 2020 | TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER |
| 3.9MG/24HR | OXYTROL FOR WOMEN | ALLERGAN | N202211 | Jan. 25, 2013 | OTC | FILM, EXTENDED RELEASE | TRANSDERMAL | 7081250 | April 26, 2020 | TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER |
| 3.9MG/24HR | OXYTROL FOR WOMEN | ALLERGAN | N202211 | Jan. 25, 2013 | OTC | FILM, EXTENDED RELEASE | TRANSDERMAL | 7081251 | April 26, 2020 | TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER |
| 3.9MG/24HR | OXYTROL FOR WOMEN | ALLERGAN | N202211 | Jan. 25, 2013 | OTC | FILM, EXTENDED RELEASE | TRANSDERMAL | 7081252 | April 26, 2020 | TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER |
| 3.9MG/24HR | OXYTROL FOR WOMEN | ALLERGAN | N202211 | Jan. 25, 2013 | OTC | FILM, EXTENDED RELEASE | TRANSDERMAL | 7179483 | April 26, 2020 | TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER |
| 3% | GELNIQUE 3% | ALLERGAN | N202513 | Dec. 7, 2011 | DISCN | GEL, METERED | TRANSDERMAL | 7029694 | April 26, 2020 | TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE |
| 3% | GELNIQUE 3% | ALLERGAN | N202513 | Dec. 7, 2011 | DISCN | GEL, METERED | TRANSDERMAL | 7179483 | April 26, 2020 | TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE |
| 3% | GELNIQUE 3% | ALLERGAN | N202513 | Dec. 7, 2011 | DISCN | GEL, METERED | TRANSDERMAL | 8241662 | April 26, 2020 | TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE |
| 10% (100MG/PACKET) | GELNIQUE | ALLERGAN | N022204 | Jan. 27, 2009 | RX | GEL | TRANSDERMAL | 10449173 | Nov. 6, 2029 | TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY FREQUENCY, URGENCY, OR URGE INCONTINENCE WITH A SINGLE UNIT DOSE OF 10% OXYBUTYNIN CHLORIDE GEL |
| 10% (100MG/PACKET) | GELNIQUE | ALLERGAN | N022204 | Jan. 27, 2009 | RX | GEL | TRANSDERMAL | 9259388 | Nov. 6, 2029 | TREATMENT OF OVERACTIVE BLADDER BY APPLICATION OF OXYBUTYNIN CHLORIDE GEL TO SKIN |
| 10% (100MG/PACKET) | GELNIQUE | ALLERGAN | N022204 | Jan. 27, 2009 | RX | GEL | TRANSDERMAL | 8920392 | March 26, 2031 | TREATMENT OF OVERACTIVE BLADDER BY APPLICATION OF OXYBUTYNIN CHLORIDE GEL TO SKIN |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Muscarinic acetylcholine receptor M1 | GPCR | ANTAGONIST | Ki | 9 | CHEMBL | DRUG LABEL | |||
| Muscarinic acetylcholine receptor M3 | GPCR | ANTAGONIST | Ki | 9.11 | CHEMBL | DRUG LABEL | |||
| 5-hydroxytryptamine receptor 2B | GPCR | Ki | 6.30 | DRUG MATRIX | |||||
| D(3) dopamine receptor | GPCR | Ki | 6.84 | DRUG MATRIX | |||||
| Sodium-dependent dopamine transporter | Transporter | Ki | 7.17 | DRUG MATRIX | |||||
| Cytochrome P450 2C19 | Enzyme | IC50 | 6.22 | DRUG MATRIX | |||||
| Muscarinic acetylcholine receptor M2 | GPCR | ANTAGONIST | Ki | 8.09 | CHEMBL | ||||
| Muscarinic acetylcholine receptor M4 | GPCR | Ki | 8.44 | CHEMBL | |||||
| Sigma non-opioid intracellular receptor 1 | Membrane receptor | Ki | 7.99 | DRUG MATRIX | |||||
| Muscarinic acetylcholine receptor M5 | GPCR | Ki | 7.85 | CHEMBL | |||||
| Sodium-dependent noradrenaline transporter | Transporter | Ki | 5.59 | DRUG MATRIX | |||||
| Membrane-associated progesterone receptor component 1 | Membrane receptor | Ki | 6.09 | DRUG MATRIX | |||||
| Muscarinic acetylcholine receptor M1 | GPCR | Ki | 8.23 | CHEMBL | |||||
| Muscarinic acetylcholine receptor M3 | GPCR | Ki | 9.02 | CHEMBL | |||||
| Muscarinic acetylcholine receptor M2 | GPCR | Ki | 8.16 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4018815 | VUID |
| N0000147118 | NUI |
| C0134394 | UMLSCUI |
| D00465 | KEGG_DRUG |
| 35768004 | SNOMEDCT_US |
| 4019869 | VANDF |
| 28244 | MMSL |
| d00328 | MMSL |
| 32675 | RXNORM |
| 372717000 | SNOMEDCT_US |
| 004715 | NDDF |
| CHEMBL1133 | ChEMBL_ID |
| CHEMBL1231 | ChEMBL_ID |
| DB01062 | DRUGBANK_ID |
| K9P6MC7092 | UNII |
| 1354 | INN_ID |
| 1508-65-2 | SECONDARY_CAS_RN |
| CHEBI:7856 | CHEBI |
| 4634 | PUBCHEM_CID |
| 359 | IUPHAR_LIGAND_ID |
| C005419 | MESH_SUPPLEMENTAL_RECORD_UI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| GELNIQUE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-5812 | GEL | 100 mg | TRANSDERMAL | NDA | 17 sections |
| GELNIQUE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-5861 | GEL | 100 mg | TRANSDERMAL | NDA | 17 sections |
| OXYTROL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-6153 | PATCH | 3.90 mg | TRANSDERMAL | NDA | 18 sections |
| Oxytrol for Women | HUMAN OTC DRUG LABEL | 1 | 0023-9637 | PATCH | 3.90 mg | TRANSDERMAL | NDA | 8 sections |
| OXYBUTYNIN CHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-5206 | TABLET, EXTENDED RELEASE | 5 mg | ORAL | ANDA | 17 sections |
| OXYBUTYNIN CHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-5207 | TABLET, EXTENDED RELEASE | 10 mg | ORAL | ANDA | 17 sections |
| OXYBUTYNIN CHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-5208 | TABLET, EXTENDED RELEASE | 15 mg | ORAL | ANDA | 17 sections |
| OXYBUTYNIN CHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0121-0671 | SYRUP | 5 mg | ORAL | ANDA | 12 sections |
| OXYBUTYNIN CHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0179-0187 | TABLET, EXTENDED RELEASE | 10 mg | ORAL | ANDA | 17 sections |
| Oxybutynin Chloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0603-4975 | TABLET | 5 mg | ORAL | ANDA | 15 sections |
| Oxybutynin Chloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-3512 | TABLET | 5 mg | ORAL | ANDA | 13 sections |
| oxybutynin chloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-7521 | TABLET, EXTENDED RELEASE | 15 mg | ORAL | NDA | 12 sections |
| oxybutynin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-8219 | TABLET, FILM COATED, EXTENDED RELEASE | 5 mg | ORAL | ANDA | 17 sections |
| Oxybutynin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-8220 | TABLET, FILM COATED, EXTENDED RELEASE | 10 mg | ORAL | ANDA | 17 sections |
| Oxybutynin Chloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0832-0038 | TABLET | 5 mg | ORAL | ANDA | 14 sections |
| Oxybutynin Chloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-2821 | TABLET | 5 mg | ORAL | ANDA | 14 sections |
| Oxybutynin Chloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-6570 | TABLET, EXTENDED RELEASE | 5 mg | ORAL | ANDA | 16 sections |
| Oxybutynin Chloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10135-609 | TABLET, EXTENDED RELEASE | 5 mg | ORAL | ANDA | 17 sections |
| Oxybutynin Chloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10135-610 | TABLET, EXTENDED RELEASE | 10 mg | ORAL | ANDA | 17 sections |
| Oxybutynin Chloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10135-611 | TABLET, EXTENDED RELEASE | 15 mg | ORAL | ANDA | 17 sections |
| Oxybutynin Chloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10135-640 | TABLET | 5 mg | ORAL | ANDA | 14 sections |
| Oxybutynin Chloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10147-0761 | TABLET, EXTENDED RELEASE | 5 mg | ORAL | NDA | 17 sections |
| Oxybutynin Chloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10147-0771 | TABLET, EXTENDED RELEASE | 10 mg | ORAL | NDA | 17 sections |
| Oxybutynin Chloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10544-518 | TABLET | 5 mg | ORAL | ANDA | 15 sections |
| Oxybutynin Chloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10544-559 | TABLET | 5 mg | ORAL | ANDA | 14 sections |
| Oxybutynin Chloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10702-201 | TABLET | 5 mg | ORAL | ANDA | 13 sections |
| Oxybutynin Chloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 14539-653 | TABLET | 5 mg | ORAL | ANDA | 13 sections |
| oxybutynin chloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-317 | TABLET, EXTENDED RELEASE | 5 mg | ORAL | ANDA | 17 sections |
| oxybutynin chloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-318 | TABLET, EXTENDED RELEASE | 10 mg | ORAL | ANDA | 17 sections |
| oxybutynin chloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-319 | TABLET, EXTENDED RELEASE | 15 mg | ORAL | ANDA | 17 sections |