APPLICATION
NDA019401
TYPE
NDA
ORIGINAL APPROVAL
1987-06-19
LATEST ACTION
1987-06-19
ROUTE
ORAL
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PSEUDO-12Discontinued
PSEUDOEPHEDRINE POLISTIREX EQ 60MG HYDROCHLORIDE/5ML · SUSPENSION, EXTENDED RELEASE · ORAL
Approval history
1987-06-19Type 2 - New Active Ingredient and Type 3 - New Dosage Form · 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.