FDA — authorised 25 November 1998
- Application: ANDA062831
- Marketing authorisation holder: SANDOZ
- Indication: Labeling
- Status: approved
🇺🇸 Ancef In Sodium Chloride 0.9% In Plastic Container in United States
FDA authorised Ancef In Sodium Chloride 0.9% In Plastic Container on 25 November 1998
Marketing authorisations
FDA — authorised 22 October 2008
- Application: ANDA065306
- Marketing authorisation holder: ACS DOBFAR
- Status: approved
FDA — authorised 29 November 2010
- Application: ANDA065303
- Marketing authorisation holder: ACS DOBFAR
- Indication: Labeling
- Status: approved
FDA — authorised 17 October 2018
- Application: ANDA209217
- Marketing authorisation holder: QILU ANTIBIOTICS
- Status: approved
FDA — authorised 26 August 2024
- Application: NDA050779
- Marketing authorisation holder: B BRAUN
- Indication: Efficacy
- Status: approved
The FDA approved Ancef In Sodium Chloride 0.9% In Plastic Container, manufactured by B Braun, on 26 August 2024. This approval was granted under the standard expedited pathway. The product is indicated for its efficacy, but the specific indication is not specified in the available data.
FDA
- Application: NDA050566
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
Ancef In Sodium Chloride 0.9% 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 Metabolic approved in United States
Frequently asked questions
Is Ancef In Sodium Chloride 0.9% In Plastic Container approved in United States?
Yes. FDA authorised it on 25 November 1998; FDA authorised it on 22 October 2008; FDA authorised it on 29 November 2010.
Who is the marketing authorisation holder for Ancef In Sodium Chloride 0.9% In Plastic Container in United States?
SANDOZ holds the US marketing authorisation.