Mercaptopurine
Mercaptopurine: 2 brands, 4 generics; first approved Feb 11, 2004; generic available.
Generic available: 4 ANDA applications approved.
Brand (NDA) products
- NOVA LABS LTDNDA 2059192014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML SUSPENSION ORAL Rx AB - PURINETHOLRLDSTASON PHARMSNDA 009053-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB
Generic (ANDA) products (4)
- MERCAPTOPURINEHIKMAANDA 2164182025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML SUSPENSION ORAL Rx AB - MERCAPTOPURINEMYLANANDA 0405942005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued - - MERCAPTOPURINERSHIKMAANDA 0405282004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - MERCAPTOPURINEDR REDDYS LABS SAANDA 0404612004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB
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.
Approval history
Approvals span 2004–2025 across 6 FDA applications.
Mercaptopurine: 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.
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