Orange Book product · Generic (ANDA)
AZITHROMYCIN
AZITHROMYCIN
At a glance
Jul 31, 2018
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 31, 2018
8 yr ago
Today
Pharmaceutical detail
Active ingredient
AZITHROMYCIN
Strength
EQ 100MG BASE/5ML
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
AB
Application
ANDA 211147
Product number
001
Marketing status
RX
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.
