Chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride
Chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride: 2 brands, 0 generics; first approved Dec 19, 2002; on patent until Feb 28, 2027.
Protected until Feb 28, 2027 (earliest listed patent expiry).
Brand (NDA) products
- HALEON US HOLDINGSNDA 0215872004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/5ML;100MG/5ML;15MG/5ML SUSPENSION ORAL OTC - - HALEON US HOLDINGSNDA 0214412002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG;200MG;30MG TABLET ORAL OTC -
Patent & exclusivity timeline
Listed patents
| Patent | Expires | In | Type |
|---|---|---|---|
| 7863287 | in 4 mo | Product |
Approval history
Approvals span 2002–2004 across 2 FDA applications.
Chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride: 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.
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- 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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