Ibuprofen sodium
Ibuprofen sodium: 1 brand, 1 generic; first approved Jun 12, 2012; generic available.
Generic available: 1 ANDA application approved.
Brand (NDA) products
- HALEON US HOLDINGSNDA 2018032012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE TABLET ORAL OTC —
Generic (ANDA) products (1)
- IBUPROFEN SODIUMPERRIGO R AND DANDA 2065812015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE TABLET ORAL Discontinued —
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 2012–2015 across 2 FDA applications.
Ibuprofen 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.
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