FDA — authorised 4 December 1997
- Application: NDA050749
- Marketing authorisation holder: ABBVIE
- Local brand name: OMNICEF
- Indication: FOR SUSPENSION — ORAL
- Status: approved
🇺🇸 Omnicef in United States
FDA authorised Omnicef on 4 December 1997
Marketing authorisations
FDA — authorised 4 December 1997
- Application: NDA050739
- Marketing authorisation holder: ABBVIE
- Local brand name: OMNICEF
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 May 2006
- Application: ANDA065264
- Marketing authorisation holder: LUPIN
- Local brand name: CEFDINIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 May 2006
- Application: ANDA065259
- Marketing authorisation holder: LUPIN
- Local brand name: CEFDINIR
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 6 April 2007
- Application: ANDA065337
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CEFDINIR
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 6 April 2007
- Application: ANDA065330
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CEFDINIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 May 2007
- Application: ANDA065332
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: CEFDINIR
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 9 May 2007
- Application: ANDA065368
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: CEFDINIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 July 2007
- Application: ANDA065429
- Marketing authorisation holder: ANDA REPOSITORY
- Local brand name: CEFDINIR
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 18 July 2007
- Application: ANDA065418
- Marketing authorisation holder: ANDA REPOSITORY
- Local brand name: CEFDINIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 January 2008
- Application: ANDA065434
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: CEFDINIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 March 2020
- Application: ANDA065473
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 19 February 2021
- Application: ANDA210220
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: CEFDINIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 February 2021
- Application: ANDA210534
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: CEFDINIR
- Indication: FOR SUSPENSION — ORAL
- Status: approved
Omnicef in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Omnicef approved in United States?
Yes. FDA authorised it on 4 December 1997; FDA authorised it on 4 December 1997; FDA authorised it on 19 May 2006.
Who is the marketing authorisation holder for Omnicef in United States?
ABBVIE holds the US marketing authorisation.