← FDA DRUG APPROVALS

FDA ANDA · ANDA089179

BELDIN

Sponsor: HALSEY

APPLICATION
ANDA089179
TYPE
ANDA
ORIGINAL APPROVAL
1986-06-05
LATEST ACTION
1992-03-11
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

BELDINDiscontinued
DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML · SYRUP · ORAL

Approval history

1992-03-11Labeling · Supplement 2AP
1991-03-08Labeling · Supplement 1AP
1986-06-05OriginalAP
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 →