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FDA ANDA · ANDA086950

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Sponsor: LEDERLE

APPLICATION
ANDA086950
TYPE
ANDA
LATEST ACTION
1983-06-16
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

1983-06-16Manufacturing (CMC) · Supplement 2AP
1983-06-16Manufacturing (CMC) · Supplement 6AP
1983-06-16Manufacturing (CMC) · Supplement 4AP
1982-09-09Manufacturing (CMC) · Supplement 3AP
1982-09-09Manufacturing (CMC) · Supplement 1AP
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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