← FDA Drug Approvals (Drugs@FDA)

BROMFENAC SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN · Approved 2023-08-15

Drug application

FDA Application #

ANDA202903

Application type

Abbreviated New Drug Application (Generic)

Brand name

BROMFENAC SODIUM

Generic name

BROMFENAC

Active ingredients

BROMFENAC SODIUM

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

Marketing status

Prescription

Sponsor

LUPIN

Manufacturer

Lupin Pharmaceuticals, Inc.

First approval

2023-08-15

Source

Authoritative

Drugs@FDA application overview

Machine

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