FDA — authorised 14 November 2005
- Application: ANDA065223
- Marketing authorisation holder: PLIVA
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Zithromax in United States
FDA authorised Zithromax on 14 November 2005
Marketing authorisations
FDA — authorised 14 November 2005
- Application: ANDA065225
- Marketing authorisation holder: PLIVA
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 July 2006
- Application: ANDA065246
- Marketing authorisation holder: PLIVA
- Local brand name: AZITHROMYCIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 18 September 2006
- Application: ANDA065297
- Marketing authorisation holder: SANDOZ
- Local brand name: AZITHROMYCIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 8 January 2007
- Application: ANDA065360
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 May 2007
- Application: ANDA065365
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 May 2007
- Application: ANDA065366
- Marketing authorisation holder: EXTROVIS
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 February 2008
- Application: ANDA065302
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 March 2009
- Application: ANDA065506
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: AZITHROMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 June 2009
- Application: ANDA065500
- Marketing authorisation holder: HOSPIRA
- Local brand name: AZITHROMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 June 2009
- Application: ANDA065511
- Marketing authorisation holder: HOSPIRA
- Local brand name: AZITHROMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 November 2009
- Application: ANDA065501
- Marketing authorisation holder: GLAND PHARMA LTD
- Local brand name: AZITHROMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 July 2011
- Application: ANDA065509
- Marketing authorisation holder: APOTEX CORP
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 2011
- Application: ANDA065508
- Marketing authorisation holder: APOTEX CORP
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 2011
- Application: ANDA065507
- Marketing authorisation holder: APOTEX CORP
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 April 2013
- Application: ANDA090923
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: AZITHROMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 June 2015
- Application: ANDA203294
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: AZITHROMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 January 2017
- Application: ANDA204732
- Marketing authorisation holder: RISING
- Local brand name: AZITHROMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 April 2018
- Application: ANDA207531
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: AZITHROMYCIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 19 July 2018
- Application: ANDA205666
- Marketing authorisation holder: AMNEAL
- Local brand name: AZITHROMYCIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 31 July 2018
- Application: ANDA211147
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: AZITHROMYCIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 24 September 2018
- Application: ANDA207566
- Marketing authorisation holder: CSPC OUYI
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 October 2018
- Application: ANDA203412
- Marketing authorisation holder: SLATE RUN PHARMA
- Status: approved
FDA — authorised 25 October 2018
- Application: ANDA208249
- Marketing authorisation holder: CSPC OUYI
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 December 2018
- Application: ANDA209043
- Marketing authorisation holder: SUNSHINE
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 December 2018
- Application: ANDA209045
- Marketing authorisation holder: SUNSHINE
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 December 2018
- Application: ANDA209044
- Marketing authorisation holder: SUNSHINE
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 December 2018
- Application: ANDA209999
- Marketing authorisation holder: BIONPHARMA
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 February 2019
- Application: ANDA210000
- Marketing authorisation holder: BIONPHARMA
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 February 2019
- Application: ANDA210001
- Marketing authorisation holder: BIONPHARMA
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 April 2019
- Application: ANDA208250
- Marketing authorisation holder: CSPC OUYI
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 December 2019
- Application: ANDA211521
- Marketing authorisation holder: TARO
- Local brand name: AZITHROMYCIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 27 January 2020
- Application: ANDA211793
- Marketing authorisation holder: ALEMBIC
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 January 2020
- Application: ANDA211792
- Marketing authorisation holder: ALEMBIC
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 January 2020
- Application: ANDA211791
- Marketing authorisation holder: ALEMBIC
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 May 2020
- Application: ANDA211068
- Marketing authorisation holder: CARLSBAD
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 March 2021
- Application: ANDA211318
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 November 2021
- Application: NDA050784
- Marketing authorisation holder: PFIZER
- Indication: Labeling
- Status: approved
FDA — authorised 12 July 2022
- Application: ANDA215773
- Marketing authorisation holder: STRIDES PHARMA
- Status: approved
FDA — authorised 15 July 2022
- Application: ANDA215772
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
The FDA approved the manufacturing (CMC) indication for Zithromax, a drug product, on 2024-07-08. The marketing authorisation holder is STRIDES PHARMA. This approval was granted under the standard expedited pathway.
FDA — authorised 26 July 2022
- Application: ANDA211317
- Marketing authorisation holder: CARLSBAD
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 April 2023
- Application: ANDA213275
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 July 2023
- Application: ANDA217036
- Marketing authorisation holder: ZHEJIANG POLY PHARM
- Local brand name: AZITHROMYCIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA202793
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: AZITHROMYCIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
Zithromax 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 Zithromax approved in United States?
Yes. FDA authorised it on 14 November 2005; FDA authorised it on 14 November 2005; FDA authorised it on 6 July 2006.
Who is the marketing authorisation holder for Zithromax in United States?
PLIVA holds the US marketing authorisation.