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Last Updated: November 4, 2024

CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for chlorpheniramine maleate; pseudoephedrine hydrochloride and what is the scope of freedom to operate?

Chlorpheniramine maleate; pseudoephedrine hydrochloride is the generic ingredient in three branded drugs marketed by Schwarz Pharma, Fisons, Cent Pharms, Graham Dm, and Kv Pharm, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Summary for CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
US Patents:0
Tradenames:3
Applicants:5
NDAs:6
Clinical Trials: 2
DailyMed Link:CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE at DailyMed
Recent Clinical Trials for CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
GlaxoSmithKlinePhase 4
Sino-American Tianjin Smith Kline & French Laboratories LtdPhase 4
Magna Pharmaceuticals, Inc.Phase 3

See all CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

US Patents and Regulatory Information for CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schwarz Pharma CODIMAL-L.A. 12 chlorpheniramine maleate; pseudoephedrine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018935-001 Apr 15, 1985 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Graham Dm PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE chlorpheniramine maleate; pseudoephedrine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018843-001 Mar 18, 1985 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Graham Dm PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE chlorpheniramine maleate; pseudoephedrine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018844-001 Mar 20, 1985 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cent Pharms PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE chlorpheniramine maleate; pseudoephedrine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019428-001 Aug 2, 1988 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fisons ISOCLOR chlorpheniramine maleate; pseudoephedrine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018747-001 Mar 6, 1986 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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