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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
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