FDA — authorised 25 March 1974
- Status: approved
🇺🇸 Brethine in United States
FDA authorised Brethine on 25 March 1974
Marketing authorisations
FDA — authorised 24 May 1979
- Application: NDA017849
- Marketing authorisation holder: ANI PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 30 November 1981
- Application: NDA018571
- Marketing authorisation holder: PHARMACARE
- Local brand name: BRETHINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 May 2004
- Application: ANDA076887
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 8 April 2011
- Application: ANDA075877
- Marketing authorisation holder: IMPAX LABS
- Indication: Labeling
- Status: approved
FDA — authorised 8 April 2011
- Application: ANDA078630
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Indication: Labeling
- Status: approved
FDA — authorised 19 June 2020
- Application: ANDA211832
- Marketing authorisation holder: TWI PHARMS
- Status: approved
Brethine in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Respiratory approved in United States
Frequently asked questions
Is Brethine approved in United States?
Yes. FDA authorised it on 25 March 1974; FDA authorised it on 24 May 1979; FDA authorised it on 30 November 1981.
Who is the marketing authorisation holder for Brethine in United States?
Marketing authorisation holder not available in our data.