FDA Orange Book · active-ingredient family
Azathioprine
Azathioprine is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:IMURAN · NDA 016324
1
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IMURANRLD×2 | LEGACY PHARMA | NDA 016324 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AZATHIOPRINE×4 | ALKEM LABS LTD | ANDA 208687 | AB | Mar 27, 2020 | |
| AZATHIOPRINE×4 | ZYDUS PHARMS USA | ANDA 077621 | AB | Sep 05, 2008 | |
| AZASAN×4 | AAIPHARMA LLC | ANDA 075252 | AB | Feb 03, 2003 | |
| AZATHIOPRINE | RISING | ANDA 075568 | AB | Dec 13, 1999 | |
| AZATHIOPRINE×3 | AMNEAL | ANDA 074069 | AB | Feb 16, 1996 |
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.
Azathioprine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
