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DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: VALEANT PHARM INTL · Approved 1997-03-05

Drug application

FDA Application #

ANDA087195

Application type

Abbreviated New Drug Application (Generic)

Brand name

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Generic name

Atropine Sulfate

Active ingredients

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Discontinued

Sponsor

VALEANT PHARM INTL

First approval

1997-03-05

Source

Authoritative

Drugs@FDA application overview

Machine

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