APPLICATION
NDA012394
TYPE
NDA
LATEST ACTION
1986-07-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DISOPHROLDiscontinued
DEXBROMPHENIRAMINE MALEATE 2MG, PSEUDOEPHEDRINE SULFATE 60MG · TABLET · ORAL
Approval history
1986-07-08Manufacturing (CMC) · Supplement 8 · 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.