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FDA ANDA · ANDA213413

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Sponsor: LEADING

APPLICATION
ANDA213413
TYPE
ANDA
ORIGINAL APPROVAL
2020-02-20
LATEST ACTION
2020-02-20
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

2020-02-20UNKNOWN · 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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