FDA — authorised 31 December 1986
- Marketing authorisation holder: BAXTER HLTHCARE
- Status: approved
🇺🇸 Brevibloc In Plastic Container in United States
FDA authorised Brevibloc In Plastic Container on 31 December 1986
Marketing authorisations
FDA — authorised 31 December 1986
- Application: NDA019386
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: BREVIBLOC IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 April 2016
- Application: NDA205703
- Marketing authorisation holder: HQ SPCLT PHARMA
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 19 March 2024
- Application: ANDA206608
- Marketing authorisation holder: MYLAN LABS LTD
- Indication: Labeling
- Status: approved
The FDA granted marketing authorisation to Mylan Labs Ltd for Brevibloc In Plastic Container on 19 March 2024. The approval was given under application number ANDA206608, which followed a standard review pathway. Brevibloc In Plastic Container is indicated for use in labeling.
FDA — authorised 4 June 2024
- Application: ANDA214172
- Marketing authorisation holder: HQ SPCLT PHARMA
- Indication: Labeling
- Status: approved
The FDA approved Brevibloc In Plastic Container, a product of HQ SPCLT PHARMA, on 2024-06-04. This approval was granted through the standard expedited pathway. The product is indicated for use as stated on the labelling.
FDA — authorised 9 July 2024
- Application: ANDA216244
- Marketing authorisation holder: EUGIA PHARMA
- Indication: Labeling
- Status: approved
The FDA approved Brevibloc In Plastic Container, a generic version of the medication, on 2024-07-09. The approval was granted to EUGIA PHARMA through a standard expedited pathway. The product is indicated for use in labeling.
Brevibloc In Plastic Container in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Brevibloc In Plastic Container approved in United States?
Yes. FDA authorised it on 31 December 1986; FDA authorised it on 31 December 1986; FDA authorised it on 7 April 2016.
Who is the marketing authorisation holder for Brevibloc In Plastic Container in United States?
BAXTER HLTHCARE holds the US marketing authorisation.