FDA Orange Book · active-ingredient family
Azathioprine sodium
Azathioprine sodium: 1 brand, 1 generic; first approved Mar 31, 1995; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 1 ANDA application approved.
Brands (NDA)
1
Generics (ANDA)
1
Listed patents
0
Presentations
2
Brand (NDA) products
Originator applications
- IMURANRLDCASPER PHARMA LLCNDA 017391—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (1)
Abbreviated applications
- AZATHIOPRINE SODIUMRSHIKMAANDA 0744191995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx —
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
31 yr 10 mo ago
Most recent approval
31 yr 10 mo ago
All 2 applications were approved in 1995.
Brand (NDA) 150%
Generic (ANDA) 150%
Azathioprine sodium: 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.
