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FDA ANDA · ANDA040357

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Sponsor: STRIDES PHARMA INTL

APPLICATION
ANDA040357
TYPE
ANDA
ORIGINAL APPROVAL
2000-05-02
LATEST ACTION
2024-09-27
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

2024-09-27Labeling · Supplement 3 · standardAP
2007-03-26Labeling · Supplement 1AP
2000-05-02OriginalAP
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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