Drug application

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDE)

Drugs@FDA ANDA 087195 · VALEANT PHARM INTL

Key facts

Drug name DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Active ingredients ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDE
Application type ANDA
Application number 087195
Company VALEANT PHARM INTL
Dosage forms TABLET, ORAL
Strength 0.025MG;2.5MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Mar 5, 1997

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents

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Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

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