FDA Orange Book · active-ingredient family
Azithromycin
Azithromycin is approved as 10 brand and 62 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AZASITE · NDA 050810
10
Brand (NDA)
62
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, for suspension, for suspension, extended release, injectable, solution/drops, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AZASITERLD | THEA PHARMA | NDA 050810 | — | Apr 27, 2007 | |
| ZMAXRLD | PF PRISM CV | NDA 050797 | — | Jun 10, 2005 | |
| ZITHROMAXRLD | PFIZER | NDA 050784 | AB | May 24, 2002 | |
| ZITHROMAXRLD | PFIZER | NDA 050733 | AP | Jan 30, 1997 | |
| ZITHROMAXRLD | PFIZER | NDA 050711 | AB | Jul 18, 1996 | |
| ZITHROMAXRLD | PFIZER | NDA 050730 | — | Jun 12, 1996 | |
| ZITHROMAXRLD×2 | PFIZER | NDA 050710 | AB | Oct 19, 1995 | |
| ZITHROMAXRLD | PFIZER | NDA 050693 | — | Sep 28, 1994 | |
| ZITHROMAXRLD | PFIZER | NDA 050670 | — | Nov 01, 1991 | |
| AZITHROMYCIN×2 | TEVA PARENTERAL | NDA 050809 | — | Dec 19, 2006 |
Generic (ANDA) products (62)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AZITHROMYCIN×2 | ZHEJIANG POLY PHARM | ANDA 217036 | AB | Jul 27, 2023 | |
| AZITHROMYCIN | ZYDUS PHARMS | ANDA 213275 | — | Apr 11, 2023 | |
| AZITHROMYCIN | ZYDUS PHARMS | ANDA 213056 | — | Apr 07, 2023 | |
| AZITHROMYCIN | CARLSBAD | ANDA 211317 | — | Jul 26, 2022 | |
| AZITHROMYCIN | STRIDES PHARMA | ANDA 215772 | AB | Jul 15, 2022 | |
| AZITHROMYCIN | STRIDES PHARMA | ANDA 215773 | AB | Jul 12, 2022 | |
| AZITHROMYCIN | PHARMOBEDIENT | ANDA 211318 | — | Mar 17, 2021 | |
| AZITHROMYCIN | CARLSBAD | ANDA 211068 | AB | May 08, 2020 | |
| AZITHROMYCIN | ALEMBIC | ANDA 211791 | AB | Jan 28, 2020 | |
| AZITHROMYCIN | ALEMBIC | ANDA 211792 | AB | Jan 28, 2020 | |
| AZITHROMYCIN | ALEMBIC | ANDA 211793 | AB | Jan 27, 2020 | |
| AZITHROMYCIN | TARO | ANDA 211521 | — | Dec 11, 2019 | |
| AZITHROMYCIN | CSPC OUYI | ANDA 208250 | AB | Apr 17, 2019 | |
| AZITHROMYCIN | BIONPHARMA | ANDA 210000 | AB | Feb 26, 2019 | |
| AZITHROMYCIN | BIONPHARMA | ANDA 210001 | AB | Feb 26, 2019 | |
| AZITHROMYCIN | BIONPHARMA | ANDA 209999 | AB | Dec 26, 2018 | |
| AZITHROMYCIN | SUNSHINE | ANDA 209045 | AB | Dec 07, 2018 | |
| AZITHROMYCIN | SUNSHINE | ANDA 209044 | AB | Dec 07, 2018 | |
| AZITHROMYCIN | SUNSHINE | ANDA 209043 | AB | Dec 06, 2018 | |
| AZITHROMYCIN | CSPC OUYI | ANDA 208249 | AB | Oct 25, 2018 | |
| AZITHROMYCIN×2 | AUROBINDO PHARMA LTD | ANDA 209201 | AB | Oct 09, 2018 | |
| AZITHROMYCIN | SLATE RUN PHARMA | ANDA 203412 | AP | Oct 09, 2018 | |
| AZITHROMYCIN | CSPC OUYI | ANDA 207566 | AB | Sep 24, 2018 | |
| AZITHROMYCIN×2 | ZYDUS LIFESCIENCES | ANDA 211147 | AB | Jul 31, 2018 | |
| AZITHROMYCIN×2 | AMNEAL | ANDA 205666 | — | Jul 19, 2018 | |
| AZITHROMYCIN | AUROBINDO PHARMA LTD | ANDA 207370 | AB | Jul 05, 2018 | |
| AZITHROMYCIN | AUROBINDO PHARMA LTD | ANDA 207398 | AB | Jul 05, 2018 | |
| AZITHROMYCIN×2 | EPIC PHARMA LLC | ANDA 207531 | AB | Apr 09, 2018 | |
| AZITHROMYCIN | RISING | ANDA 204732 | — | Jan 26, 2017 | |
| AZITHROMYCIN | EUGIA PHARMA | ANDA 203294 | AP | Jun 19, 2015 | |
| AZITHROMYCIN×2 | CHARTWELL RX | ANDA 065488 | AB | May 15, 2015 | |
| AZITHROMYCIN | LUPIN | ANDA 065398 | AB | May 15, 2015 | |
| AZITHROMYCIN | LUPIN | ANDA 065399 | AB | May 15, 2015 | |
| AZITHROMYCIN | LUPIN | ANDA 065400 | AB | May 15, 2015 | |
| AZITHROMYCIN | SUN PHARM INDS LTD | ANDA 090923 | — | Apr 02, 2013 | |
| AZITHROMYCIN | APOTEX CORP | ANDA 065507 | — | Jul 13, 2011 | |
| AZITHROMYCIN | APOTEX CORP | ANDA 065509 | — | Jul 13, 2011 | |
| AZITHROMYCIN | APOTEX CORP | ANDA 065508 | — | Jul 13, 2011 | |
| AZITHROMYCIN | GLAND PHARMA LTD | ANDA 065501 | AP | Nov 09, 2009 | |
| AZITHROMYCIN | HOSPIRA | ANDA 065500 | AP | Jun 26, 2009 | |
| AZITHROMYCIN | HOSPIRA | ANDA 065511 | — | Jun 26, 2009 | |
| AZITHROMYCIN | PHARMOBEDIENT | ANDA 065506 | — | Mar 24, 2009 | |
| AZITHROMYCIN×2 | TEVA PHARMS | ANDA 065419 | — | Jun 24, 2008 | |
| AZITHROMYCIN | CHARTWELL RX | ANDA 065404 | AB | Feb 11, 2008 | |
| AZITHROMYCIN | CHARTWELL RX | ANDA 065405 | AB | Feb 11, 2008 | |
| AZITHROMYCIN | CHARTWELL RX | ANDA 065302 | AB | Feb 11, 2008 | |
| AZITHROMYCIN | EXTROVIS | ANDA 065366 | — | May 30, 2007 | |
| AZITHROMYCIN | PHARMOBEDIENT | ANDA 065365 | — | May 30, 2007 | |
| AZITHROMYCIN | HIKMA | ANDA 065265 | — | Jan 18, 2007 | |
| AZITHROMYCIN | AUROBINDO PHARMA USA | ANDA 065360 | — | Jan 08, 2007 | |
| AZITHROMYCIN×2 | SANDOZ | ANDA 065297 | — | Sep 18, 2006 | |
| AZITHROMYCIN×2 | PLIVA | ANDA 065246 | AB | Jul 05, 2006 | |
| AZITHROMYCIN | FRESENIUS KABI USA | ANDA 065179 | AP | Dec 13, 2005 | |
| AZITHROMYCIN | PLIVA | ANDA 065225 | AB | Nov 14, 2005 | |
| AZITHROMYCIN | PLIVA | ANDA 065223 | AB | Nov 14, 2005 | |
| AZITHROMYCIN | PLIVA | ANDA 065218 | AB | Nov 14, 2005 | |
| AZITHROMYCIN | SANDOZ | ANDA 065211 | AB | Nov 14, 2005 | |
| AZITHROMYCIN | SANDOZ | ANDA 065212 | AB | Nov 14, 2005 | |
| AZITHROMYCIN | SANDOZ | ANDA 065209 | AB | Nov 14, 2005 | |
| AZITHROMYCIN | TEVA | ANDA 065153 | — | Nov 14, 2005 | |
| AZITHROMYCIN | TEVA | ANDA 065193 | AB | Nov 14, 2005 | |
| AZITHROMYCIN | TEVA | ANDA 065150 | — | Nov 14, 2005 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Azithromycin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
