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ATROPINE SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SOMERSET THERAPS LLC · Approved 2024-11-29

Drug application

FDA Application #

ANDA215005

Application type

Abbreviated New Drug Application (Generic)

Brand name

ATROPINE SULFATE

Generic name

ATROPINE SULFATE MONOHYDRATE

Active ingredients

ATROPINE SULFATE

Dosage form

SOLUTION

Route

INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL

Marketing status

Prescription

Sponsor

SOMERSET THERAPS LLC

Manufacturer

Somerset Therapeutics, LLC

First approval

2024-11-29

Source

Authoritative

Drugs@FDA application overview

Machine

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