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DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 1982-03-15

Drug application

FDA Application #

ANDA087765

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

HIKMA

First approval

1982-03-15

Source

Authoritative

Drugs@FDA application overview

Machine

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