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ATROPINE SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 2025-10-24

Drug application

FDA Application #

ANDA217345

Application type

Abbreviated New Drug Application (Generic)

Brand name

ATROPINE SULFATE

Generic name

ATROPINE SULFATE

Active ingredients

ATROPINE SULFATE

Dosage form

SOLUTION

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

HIKMA

Manufacturer

Hikma Pharmaceuticals USA Inc.

First approval

2025-10-24

Source

Authoritative

Drugs@FDA application overview

Machine

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