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FDA ANDA · ANDA086727

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Sponsor: ANI PHARMS

APPLICATION
ANDA086727
TYPE
ANDA
ORIGINAL APPROVAL
1979-10-29
LATEST ACTION
2025-09-19
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

2025-09-19Manufacturing (CMC) · Supplement 55 · unknownAP
2024-10-11Labeling · Supplement 46 · standardAP
2007-06-19Manufacturing (CMC) · Supplement 44AP
2002-07-29Manufacturing (CMC) · Supplement 38AP
2001-09-12Manufacturing (CMC) · Supplement 36AP
2000-08-15Manufacturing (CMC) · Supplement 35AP
2000-05-05Labeling · Supplement 34AP
2000-05-05Manufacturing (CMC) · Supplement 32AP
2000-05-05Manufacturing (CMC) · Supplement 33AP
2000-01-28Manufacturing (CMC) · Supplement 31AP
1999-11-18Manufacturing (CMC) · Supplement 30AP
1999-11-18Manufacturing (CMC) · Supplement 29AP
1999-11-18Manufacturing (CMC) · Supplement 28AP
1999-03-12Manufacturing (CMC) · Supplement 27AP
1998-09-24Labeling · Supplement 26AP
1988-01-20Manufacturing (CMC) · Supplement 24AP
1988-01-20Manufacturing (CMC) · Supplement 25AP
1987-01-14Manufacturing (CMC) · Supplement 20AP
1987-01-14Manufacturing (CMC) · Supplement 19AP
1979-10-29OriginalAP
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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