FDA — authorised 25 August 2005
- Application: ANDA065250
- Marketing authorisation holder: ANI PHARMS
- Local brand name: CLARITHROMYCIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Klaricid in United States
FDA authorised Klaricid on 25 August 2005
Marketing authorisations
FDA — authorised 31 May 2006
- Application: ANDA065266
- Marketing authorisation holder: WOCKHARDT
- Local brand name: CLARITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 September 2007
- Application: ANDA065283
- Marketing authorisation holder: SANDOZ
- Local brand name: CLARITHROMYCIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 15 September 2015
- Application: ANDA202532
- Marketing authorisation holder: LUPIN
- Local brand name: CLARITHROMYCIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 September 2015
- Application: ANDA203584
- Marketing authorisation holder: HEC PHARM
- Local brand name: CLARITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 February 2016
- Application: ANDA203243
- Marketing authorisation holder: MPP PHARMA
- Local brand name: CLARITHROMYCIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 9 July 2018
- Application: ANDA208987
- Marketing authorisation holder: SUNSHINE
- Local brand name: CLARITHROMYCIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 25 April 2019
- Application: ANDA206714
- Marketing authorisation holder: JUBILANT CADISTA
- Local brand name: CLARITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 2022
- Application: ANDA210459
- Marketing authorisation holder: ALEMBIC
- Local brand name: CLARITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Klaricid approved in United States?
Yes. FDA authorised it on 25 August 2005; FDA authorised it on 31 May 2006; FDA authorised it on 4 September 2007.
Who is the marketing authorisation holder for Klaricid in United States?
ANI PHARMS holds the US marketing authorisation.