← FDA DRUG APPROVALS

FDA ANDA · ANDA088870

PHERAZINE VC W/ CODEINE

Sponsor: HALSEY

APPLICATION
ANDA088870
TYPE
ANDA
ORIGINAL APPROVAL
1987-03-02
LATEST ACTION
1989-02-16
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

PHERAZINE VC W/ CODEINEDiscontinued
CODEINE PHOSPHATE 10MG/5ML, PHENYLEPHRINE HYDROCHLORIDE 5MG/5ML, PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SYRUP · ORAL

Approval history

1989-02-16Labeling · Supplement 3AP
1987-03-02OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →