FDA — authorised 16 April 1959
- Status: approved
🇺🇸 Tofranil in United States
FDA authorised Tofranil on 16 April 1959
Marketing authorisations
FDA — authorised 2 October 1959
- Application: NDA011838
- Marketing authorisation holder: NOVARTIS
- Local brand name: TOFRANIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 April 2010
- Application: ANDA090444
- Marketing authorisation holder: LUPIN LTD
- Status: approved
FDA — authorised 21 February 2014
- Application: ANDA091099
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
FDA — authorised 20 December 2024
- Application: ANDA040751
- Marketing authorisation holder: OXFORD PHARMS
- Indication: Labeling
- Status: approved
The FDA granted marketing authorisation to OXFORD PHARMS for Tofranil on 20 December 2024. Tofranil is approved for use in the United States. The marketing authorisation holder is OXFORD PHARMS, and the application number is ANDA040751.
FDA — authorised 24 June 2025
- Application: ANDA090441
- Marketing authorisation holder: CHARTWELL
- Indication: Labeling
- Status: approved
The FDA approved Tofranil, manufactured by Chartwell, for its approved indication on 24 June 2025. This approval was granted through the standard expedited pathway. The application number for this approval is ANDA090441.
FDA — authorised 24 June 2025
- Application: ANDA040903
- Marketing authorisation holder: LEADING
- Indication: Labeling
- Status: approved
The FDA approved Tofranil, a medication, on 24 June 2025. The approval was granted to LEADING, the marketing authorisation holder, under the standard expedited pathway. The indication approved is for the drug's labeling, but the specific local brand name is not reported.
Tofranil in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Tofranil approved in United States?
Yes. FDA authorised it on 16 April 1959; FDA authorised it on 2 October 1959; FDA authorised it on 16 April 2010.
Who is the marketing authorisation holder for Tofranil in United States?
Marketing authorisation holder not available in our data.