Orange Book product · Generic (ANDA)
AZITHROMYCIN
AZITHROMYCIN
At a glance
Mar 17, 2021
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 17, 2021
5 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
AZITHROMYCIN
Strength
EQ 500MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 211318
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of AZITHROMYCIN
- 2007AZASITEBrand (NDA)
NDA 050810 · THEA PHARMA
- 2006AZITHROMYCINBrand (NDA)
NDA 050809 · TEVA PARENTERAL
- 2005ZMAXBrand (NDA)
NDA 050797 · PF PRISM CV
- 1997ZITHROMAXBrand (NDA)
NDA 050733 · PFIZER
- 1995ZITHROMAXBrand (NDA)
NDA 050710 · PFIZER
- 1994ZITHROMAXBrand (NDA)
NDA 050693 · PFIZER
- 1991ZITHROMAXBrand (NDA)
NDA 050670 · PFIZER
- 2023AZITHROMYCINGeneric (ANDA)
ANDA 217036 · ZHEJIANG POLY PHARM
- 2022AZITHROMYCINGeneric (ANDA)
ANDA 211317 · CARLSBAD
- 2020AZITHROMYCINGeneric (ANDA)
ANDA 211068 · CARLSBAD
- 2020AZITHROMYCINGeneric (ANDA)
ANDA 211791 · ALEMBIC
- 2020AZITHROMYCINGeneric (ANDA)
ANDA 211792 · ALEMBIC
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.
