← FDA DRUG APPROVALS
FDA NDA · NDA018843
PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
Sponsor: GRAHAM DM
APPLICATION
NDA018843
TYPE
NDA
ORIGINAL APPROVAL
1985-03-18
LATEST ACTION
1997-06-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATEDiscontinued
CHLORPHENIRAMINE MALEATE 12MG, PSEUDOEPHEDRINE HYDROCHLORIDE 120MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
1997-06-25Labeling · Supplement 5AP
1985-03-18Type 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.