Orange Book product · Brand (NDA)
ZMAX
AZITHROMYCIN
At a glance
Jun 10, 2005
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 10, 2005
21 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
AZITHROMYCIN
Strength
EQ 2GM BASE/BOT
Dosage form
FOR SUSPENSION, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 050797
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2007AZASITEBrand (NDA)
NDA 050810 · THEA PHARMA
- 2006AZITHROMYCINBrand (NDA)
NDA 050809 · TEVA PARENTERAL
- 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
- 2020AZITHROMYCINGeneric (ANDA)
ANDA 211793 · 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.
