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FDA ANDA · ANDA085762

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Sponsor: QUAGEN

APPLICATION
ANDA085762
TYPE
ANDA
ORIGINAL APPROVAL
1977-11-17
LATEST ACTION
2024-08-13
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

2024-08-13Labeling · Supplement 64 · standardAP
2010-11-30Labeling · Supplement 62AP
1998-04-15Manufacturing (CMC) · Supplement 52AP
1998-02-05Manufacturing (CMC) · Supplement 51AP
1997-05-09Manufacturing (CMC) · Supplement 50AP
1995-06-05Labeling · Supplement 49AP
1993-12-29Manufacturing (CMC) · Supplement 48AP
1990-08-15Labeling · Supplement 46AP
1990-01-31Manufacturing (CMC) · Supplement 45AP
1987-11-17Manufacturing (CMC) · Supplement 44AP
1983-05-09Manufacturing (CMC) · Supplement 38AP
1977-11-17OriginalAP
VIEW ON DRUGS@FDA ↗

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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.

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