FDA Orange Book · active-ingredient family
Allopurinol sodium
Allopurinol sodium: 1 brand, 2 generics; first approved May 17, 1996; generic available.
Generic available
Generic status & protection
Generic available: 2 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
2
Listed patents
0
Presentations
3
Brand (NDA) products
Originator applications
- MYLANNDA 0202981996
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP
Generic (ANDA) products (2)
Abbreviated applications
- ALLOPURINOL SODIUMGLANDANDA 2123632022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - ALLOPURINOL SODIUMHIKMAANDA 0768702004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP
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 8 mo ago
Most recent approval
4 yr 7 mo ago
Approvals span 1996–2022 across 3 FDA applications.
Brand (NDA) 133%
Generic (ANDA) 267%
Allopurinol 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.
