← FDA Drug Approvals (Drugs@FDA)

NAPROXEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2021-03-10

Drug application

FDA Application #

ANDA211910

Application type

Abbreviated New Drug Application (Generic)

Brand name

NAPROXEN

Generic name

NAPROXEN ORAL

Active ingredients

NAPROXEN

Dosage form

SUSPENSION

Route

ORAL

Marketing status

Prescription

Sponsor

NOVITIUM PHARMA

Manufacturer

ANI Pharmaceuticals, Inc.

First approval

2021-03-10

Source

Authoritative

Drugs@FDA application overview

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