FDA Orange Book · active-ingredient family
Dexchlorpheniramine maleate
Dexchlorpheniramine maleate: 0 brands, 5 generics; first approved Jul 19, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 5 ANDA applications approved.
Brands (NDA)
0
Generics (ANDA)
5
Listed patents
0
Presentations
5
Generic (ANDA) products (5)
Abbreviated applications
- POLMONRSPHARMOBEDIENTANDA 2025202018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/5ML SYRUP ORAL Rx — - DEXCHLORPHENIRAMINE MALEATEANI PHARMSANDA 0886821986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued — - DEXCHLORPHENIRAMINE MALEATERLDPAI HOLDINGS PHARMANDA 0882511984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/5ML SYRUP ORAL Discontinued — - SCHERINGANDA 0868371982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/5ML SYRUP ORAL Discontinued — - POLARAMINERLDSCHERINGANDA 086835—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued —
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
44 yr 9 mo ago
Most recent approval
8 yr 2 mo ago
Approvals span 1982–2018 across 5 FDA applications.
Brand (NDA) 00%
Generic (ANDA) 5100%
Dexchlorpheniramine maleate: 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
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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.
