FDA — authorised 1 November 1991
- Application: NDA050670
- Marketing authorisation holder: PFIZER
- Local brand name: ZITHROMAX
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Zithromax in United States
FDA authorised Zithromax on 1 November 1991
Marketing authorisations
FDA — authorised 28 September 1994
- Application: NDA050693
- Marketing authorisation holder: PFIZER
- Local brand name: ZITHROMAX
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 19 October 1995
- Application: NDA050710
- Marketing authorisation holder: PFIZER
- Local brand name: ZITHROMAX
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 12 June 1996
- Application: NDA050730
- Marketing authorisation holder: PFIZER
- Local brand name: ZITHROMAX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 July 1996
- Application: NDA050711
- Marketing authorisation holder: PFIZER
- Local brand name: ZITHROMAX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 January 1997
- Application: NDA050733
- Marketing authorisation holder: PFIZER
- Local brand name: ZITHROMAX
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 May 2002
- Application: NDA050784
- Marketing authorisation holder: PFIZER
- Local brand name: ZITHROMAX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 November 2005
- Application: ANDA065223
- Marketing authorisation holder: PLIVA
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 November 2005
- Application: ANDA065150
- Marketing authorisation holder: TEVA
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 November 2005
- Application: ANDA065153
- Marketing authorisation holder: TEVA
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 November 2005
- Application: ANDA065225
- Marketing authorisation holder: PLIVA
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 December 2005
- Application: ANDA065179
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: AZITHROMYCIN
- Indication: INJECTABLE — INJECTION
- 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 18 January 2007
- Application: ANDA065265
- Marketing authorisation holder: HIKMA
- Local brand name: AZITHROMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 May 2007
- Application: ANDA065366
- Marketing authorisation holder: EXTROVIS
- 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 11 February 2008
- Application: ANDA065405
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 February 2008
- Application: ANDA065404
- Marketing authorisation holder: CHARTWELL RX
- 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 June 2008
- Application: ANDA065419
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: AZITHROMYCIN
- Indication: FOR SUSPENSION — 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 15 May 2015
- Application: ANDA065400
- Marketing authorisation holder: LUPIN
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 May 2015
- Application: ANDA065399
- Marketing authorisation holder: LUPIN
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 May 2015
- Application: ANDA065398
- Marketing authorisation holder: LUPIN
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- 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
- Local brand name: AZITHROMYCIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 October 2018
- Application: ANDA209201
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: AZITHROMYCIN
- Indication: FOR SUSPENSION — ORAL
- 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: ANDA211791
- 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 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 12 July 2022
- Application: ANDA215773
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 July 2022
- Application: ANDA215772
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: AZITHROMYCIN
- Indication: TABLET — ORAL
- Status: approved
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
- Status: approved
FDA
- Application: ANDA202308
- Marketing authorisation holder: SANDOZ INC
- Local brand name: AZITHROMYCIN
- Indication: SOLUTION — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA202793
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: AZITHROMYCIN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
Pricing & reimbursement
- annual_list: USD 1000.00 per year
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 1 November 1991; FDA authorised it on 28 September 1994; FDA authorised it on 19 October 1995.
Who is the marketing authorisation holder for Zithromax in United States?
PFIZER holds the US marketing authorisation.
What does Zithromax cost in United States?
annual_list: USD 1000.00 per year. Final patient cost depends on reimbursement and any patient access scheme.