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DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ANI PHARMS · Approved 1979-10-29

Drug application

FDA Application #

ANDA086727

Application type

Abbreviated New Drug Application (Generic)

Brand name

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Generic name

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Active ingredients

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ANI PHARMS

Manufacturer

ANI Pharmaceuticals, Inc.

First approval

1979-10-29

Source

Authoritative

Drugs@FDA application overview

Machine

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