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FDA ANDA · ANDA087842

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Sponsor: USL PHARMA

APPLICATION
ANDA087842
TYPE
ANDA
ORIGINAL APPROVAL
1982-03-29
LATEST ACTION
1986-05-09
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

1986-05-09Manufacturing (CMC) · Supplement 2AP
1986-05-09Manufacturing (CMC) · Supplement 3AP
1982-03-29OriginalAP
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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