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FDA ANDA · ANDA210819

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Sponsor: UNICHEM

APPLICATION
ANDA210819
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-13
LATEST ACTION
2018-11-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEPrescription
ATROPINE SULFATE 0.025MG, DIPHENOXYLATE HYDROCHLORIDE 2.5MG · TABLET · ORAL

Approval history

2018-11-13UNKNOWN · Original · standardAP
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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