FDA — authorised 28 July 1966
- Application: NDA014740
- Marketing authorisation holder: ROCHE
- Local brand name: MENRIUM 5-2
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 benzodiazepines in United States
FDA authorised benzodiazepines on 28 July 1966
Marketing authorisations
FDA — authorised 12 September 1983
- Application: NDA017813
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: LIBRELEASE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA085481
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: LIBRITABS
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085482
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: LIBRITABS
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085488
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: LIBRITABS
- Indication: TABLET — ORAL
- Status: approved
Other Other approved in United States
Frequently asked questions
Is benzodiazepines approved in United States?
Yes. FDA authorised it on 28 July 1966; FDA authorised it on 12 September 1983; FDA has authorised it.
Who is the marketing authorisation holder for benzodiazepines in United States?
ROCHE holds the US marketing authorisation.