Active substance
Oxazepam
- US FDA 24
- Health Canada 9
- US price lines 3
- NHS prices 2
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| OXAZEPAM | 30MG; 10MG; 15MG | capsule · oral | TP ANDA HOLDINGS | Prescription | 10 Aug 1987 |
| OXAZEPAM | 30MG; 10MG; 15MG | capsule · oral | ACTAVIS ELIZABETH | Prescription | 14 Apr 1988 |
| OXAZEPAM | 15MG; 10MG; 30MG | capsule · oral | EPIC PHARMA LLC | Prescription | 19 Apr 1988 |
| OXAZEPAM | 10MG; 15MG; 30MG | capsule · oral | LEADING | Prescription | 3 Mar 2025 |
| SERAX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | capsule · oral | ALPHARMA US PHARMS | Discontinued | 4 Jun 1965 |
| SERAX | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | ALPHARMA US PHARMS | Discontinued | 4 Jun 1965 |
| OXAZEPAM | 15MG | tablet · oral | SUN PHARM INDUSTRIES | Discontinued | 16 Jan 1987 |
| OXAZEPAM | 15MG | tablet · oral | WATSON LABS | Discontinued | 21 Apr 1987 |
| OXAZEPAM | 10MG | capsule · oral | IVAX SUB TEVA PHARMS | Discontinued | 3 Aug 1987 |
| OXAZEPAM | 15MG | capsule · oral | IVAX SUB TEVA PHARMS | Discontinued | 3 Aug 1987 |
| OXAZEPAM | 30MG | capsule · oral | IVAX SUB TEVA PHARMS | Discontinued | 3 Aug 1987 |
| OXAZEPAM | 10MG | capsule · oral | WATSON LABS TEVA | Discontinued | 28 Sep 1990 |
| OXAZEPAM | 15MG | capsule · oral | WATSON LABS | Discontinued | 28 Sep 1990 |
| OXAZEPAM | 30MG | capsule · oral | WATSON LABS | Discontinued | 28 Sep 1990 |
| ZAXOPAM | 15MG | capsule · oral | QUANTUM PHARMICS | Discontinued | |
| ZAXOPAM | 30MG | capsule · oral | QUANTUM PHARMICS | Discontinued | |
| ZAXOPAM | 10MG | capsule · oral | QUANTUM PHARMICS | Discontinued | |
| OXAZEPAM | 15MG | tablet · oral | PARKE DAVIS | Discontinued | |
| OXAZEPAM | 10MG | capsule · oral | MYLAN | Discontinued | |
| OXAZEPAM | 15MG | capsule · oral | MYLAN | Discontinued | |
| OXAZEPAM | 30MG | capsule · oral | MYLAN | Discontinued | |
| OXAZEPAM | 10MG | capsule · oral | AM THERAP | Discontinued | |
| OXAZEPAM | 15MG | capsule · oral | AM THERAP | Discontinued | |
| OXAZEPAM | 30MG | capsule · oral | AM THERAP | Discontinued |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-OXAZEPAM | 00402680 | 10 MG | TABLET · ORAL | APOTEX INC |
| APO-OXAZEPAM | 00402737 | 30 MG | TABLET · ORAL | APOTEX INC |
| APO-OXAZEPAM | 00402745 | 15 MG | TABLET · ORAL | APOTEX INC |
| PRO-OXAZEPAM | 00497754 | 10 MG | TABLET · ORAL | PRO DOC LIMITEE |
| PRO-OXAZEPAM | 00497762 | 15 MG | TABLET · ORAL | PRO DOC LIMITEE |
| PRO-OXAZEPAM | 00497770 | 30 MG | TABLET · ORAL | PRO DOC LIMITEE |
| RIVA-OXAZEPAM | 00568392 | 10 MG | TABLET · ORAL | LABORATOIRE RIVA INC. |
| RIVA-OXAZEPAM | 00568406 | 15 MG | TABLET · ORAL | LABORATOIRE RIVA INC. |
| RIVA-OXAZEPAM | 00568414 | 30 MG | TABLET · ORAL | LABORATOIRE RIVA INC. |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | OXAZEPAM 10 MG CAPSULE | $0.72474 | per EA | 23 Sep 2026 |
| US NADAC | OXAZEPAM 15 MG CAPSULE | $0.88374 | per EA | 23 Sep 2026 |
| US NADAC | OXAZEPAM 30 MG CAPSULE | $1.34943 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Oxazepam 10mg tablets | £9.59 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Oxazepam 15mg tablets | £11.21 | 28 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- EMA PRAC 7 May 2026 PRAC signal: Miscarriage associated with in utero exposure to benzodiazepines (including fixed-dose combinations)
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.