← FDA DRUG APPROVALS

FDA ANDA · ANDA085372

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Sponsor: LANNETT

APPLICATION
ANDA085372
TYPE
ANDA
ORIGINAL APPROVAL
1978-02-21
LATEST ACTION
2024-08-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2024-08-07Labeling · Supplement 16 · standardAP
2024-08-07Labeling · Supplement 15 · standardAP
2024-08-07Labeling · Supplement 21 · standardAP
2017-12-20Manufacturing (CMC) · Supplement 14 · unknownAP
2008-02-29Labeling · Supplement 11AP
2007-03-28Labeling · Supplement 9AP
2002-08-26Manufacturing (CMC) · Supplement 7AP
2000-10-26Manufacturing (CMC) · Supplement 6AP
2000-10-26Manufacturing (CMC) · Supplement 4AP
2000-10-26Manufacturing (CMC) · Supplement 5AP
2000-08-14Manufacturing (CMC) · Supplement 2AP
2000-08-14Labeling · Supplement 1AP
2000-08-10Manufacturing (CMC) · Supplement 3AP
1978-02-21OriginalAP
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 →