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ATROPINE SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SOMERSET · Approved 2024-04-29

Drug application

FDA Application #

ANDA217791

Application type

Abbreviated New Drug Application (Generic)

Brand name

ATROPINE SULFATE

Generic name

ATROPINE SULFATE MONOHYDRATE

Active ingredients

ATROPINE SULFATE

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

Marketing status

Prescription

Sponsor

SOMERSET

Manufacturer

Somerset Therapeutics, LLC

First approval

2024-04-29

Source

Authoritative

Drugs@FDA application overview

Machine

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