← FDA DRUG APPROVALS
FDA NDA · NDA019428
PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
Sponsor: CENT PHARMS
APPLICATION
NDA019428
TYPE
NDA
ORIGINAL APPROVAL
1988-08-02
LATEST ACTION
1992-07-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATEDiscontinued
CHLORPHENIRAMINE MALEATE 8MG, PSEUDOEPHEDRINE HYDROCHLORIDE 120MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
1992-07-16Manufacturing (CMC) · Supplement 3 · standardAP
1988-08-02Type 5 - New Formulation or New Manufacturer · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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