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FDA ANDA · ANDA085509

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Sponsor: INWOOD LABS

APPLICATION
ANDA085509
TYPE
ANDA
ORIGINAL APPROVAL
1978-03-09
LATEST ACTION
1978-03-09
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

1978-03-09OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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