← FDA DRUG APPROVALS

FDA ANDA · ANDA206660

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Sponsor: SCIEGEN PHARMS

APPLICATION
ANDA206660
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-15
LATEST ACTION
2023-12-15
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDEDiscontinued
CHLORPHENIRAMINE MALEATE 4MG/5ML, HYDROCODONE BITARTRATE 5MG/5ML, PSEUDOEPHEDRINE HYDROCHLORIDE 60MG/5ML · SOLUTION · ORAL

Approval history

2023-12-15Labeling · Supplement 4 · standardAP
2017-05-15UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →