Is there a generic for Dexchlorpheniramine maleate?

Yes. The FDA Orange Book lists 5 approved generic (ANDA) applications for Dexchlorpheniramine maleate. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What dosage forms of Dexchlorpheniramine maleate are approved?

Dexchlorpheniramine maleate is approved in the following dosage forms: syrup, tablet.

FDA Orange Book · active-ingredient family

Dexchlorpheniramine maleate

Dexchlorpheniramine maleate is approved in 5 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Generic (ANDA) products (5)

Product	Applicant	Application	TE	Approved
POLMON	PHARMOBEDIENT	ANDA 202520	—	Jul 16, 2018
DEXCHLORPHENIRAMINE MALEATE	ANI PHARMS	ANDA 088682	—	Jan 17, 1986
DEXCHLORPHENIRAMINE MALEATERLD	PAI HOLDINGS PHARM	ANDA 088251	—	Mar 23, 1984
POLARAMINE	SCHERING	ANDA 086837	—	Jul 19, 1982
POLARAMINERLD	SCHERING	ANDA 086835	—	Approved Prior to Jan 1, 1982

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.

Dexchlorpheniramine maleate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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