FDA — authorised 20 November 1964
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: approved
🇺🇸 Norpramin in United States
FDA authorised Norpramin on 20 November 1964
Marketing authorisations
FDA — authorised 20 November 1964
- Application: NDA014399
- Marketing authorisation holder: VALIDUS PHARMS
- Local brand name: NORPRAMIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 April 1999
- Application: ANDA074430
- Marketing authorisation holder: ACTAVIS TOTOWA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 30 September 2019
- Application: ANDA204963
- Marketing authorisation holder: INGENUS PHARMS LLC
- Indication: Labeling
- Status: approved
FDA — authorised 5 June 2023
- Application: ANDA208105
- Marketing authorisation holder: AMNEAL PHARMS CO
- Indication: Labeling
- Status: approved
FDA — authorised 6 September 2024
- Application: ANDA071588
- Marketing authorisation holder: ACTAVIS TOTOWA
- Indication: Labeling
- Status: approved
The FDA approved Norpramin for labeling indications. This approval was granted to ACTAVIS TOTOWA on 2024-09-06. The application number for this approval is ANDA071588.
Norpramin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Norpramin approved in United States?
Yes. FDA authorised it on 20 November 1964; FDA authorised it on 20 November 1964; FDA authorised it on 7 April 1999.
Who is the marketing authorisation holder for Norpramin in United States?
SANOFI AVENTIS US holds the US marketing authorisation.