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FDA ANDA · ANDA085506

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Sponsor: SUN PHARM INDUSTRIES

APPLICATION
ANDA085506
TYPE
ANDA
ORIGINAL APPROVAL
1977-06-03
LATEST ACTION
1998-12-01
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

1998-12-01Manufacturing (CMC) · Supplement 65AP
1994-12-23Manufacturing (CMC) · Supplement 64AP
1993-09-21Labeling · Supplement 63AP
1992-04-03Manufacturing (CMC) · Supplement 60AP
1992-04-03Manufacturing (CMC) · Supplement 62AP
1991-02-15Labeling · Supplement 59AP
1987-04-10Manufacturing (CMC) · Supplement 47AP
1983-04-07Manufacturing (CMC) · Supplement 38AP
1977-06-03OriginalAP
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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