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FDA NDA · NDA018844
PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
Sponsor: GRAHAM DM
APPLICATION
NDA018844
TYPE
NDA
ORIGINAL APPROVAL
1985-03-20
LATEST ACTION
1985-03-20
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
1985-03-20Type 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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