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ATROPINE SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 2021-12-01

Drug application

FDA Application #

ANDA213561

Application type

Abbreviated New Drug Application (Generic)

Brand name

ATROPINE SULFATE

Generic name

ATROPINE SULFATE

Active ingredients

ATROPINE SULFATE

Dosage form

SOLUTION

Route

INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL

Marketing status

Prescription

Sponsor

HIKMA

Manufacturer

Hikma Pharmaceuticals USA Inc.

First approval

2021-12-01

Source

Authoritative

Drugs@FDA application overview

Machine

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