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FDA ANDA · ANDA087765

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Sponsor: HIKMA

APPLICATION
ANDA087765
TYPE
ANDA
ORIGINAL APPROVAL
1982-03-15
LATEST ACTION
1991-03-28
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

1991-03-28Manufacturing (CMC) · Supplement 9AP
1984-10-10Manufacturing (CMC) · Supplement 3AP
1982-03-15OriginalAP
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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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