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ATROPINE SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: EDENBRIDGE PHARMS · Approved 2026-04-15

Drug application

FDA Application #

ANDA219013

Application type

Abbreviated New Drug Application (Generic)

Brand name

ATROPINE SULFATE

Generic name

ATROPINE SULFATE

Active ingredients

ATROPINE SULFATE

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

Marketing status

Prescription

Sponsor

EDENBRIDGE PHARMS

Manufacturer

Edenbridge Pharmaceuticals LLC.

First approval

2026-04-15

Source

Authoritative

Drugs@FDA application overview

Machine

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