← FDA DRUG APPROVALS

FDA ANDA · ANDA085659

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Sponsor: KV PHARM

APPLICATION
ANDA085659
TYPE
ANDA
ORIGINAL APPROVAL
1978-01-27
LATEST ACTION
1988-10-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDiscontinued
ATROPINE SULFATE 0.025MG, DIPHENOXYLATE HYDROCHLORIDE 2.5MG · TABLET · ORAL

Approval history

1988-10-17Labeling · Supplement 5AP
1978-01-27OriginalAP
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 →