FDA Orange Book · active-ingredient family
Azathioprine
Azathioprine: 1 brand, 5 generics; first approved Feb 16, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 5 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
5
Listed patents
0
Presentations
18
Brand (NDA) products
Originator applications
- IMURANRLDLEGACYNDA 016324—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 25MG TABLET ORAL Discontinued —
Generic (ANDA) products (5)
Abbreviated applications
- AZATHIOPRINEALKEM LABS LTDANDA 20868720204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - AZATHIOPRINEZYDUS PHARMS USAANDA 07762120084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - AAIPHARMA LLCANDA 07525220034 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - AZATHIOPRINERISINGANDA 0755681999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - AZATHIOPRINEAMNEALANDA 07406919963 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
30 yr 11 mo ago
Most recent approval
4 yr 10 mo ago
Approvals span 1996–2021 across 6 FDA applications.
Brand (NDA) 117%
Generic (ANDA) 583%
Azathioprine: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
