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NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS CO · Approved 2018-10-23

Drug application

FDA Application #

ANDA209726

Application type

Abbreviated New Drug Application (Generic)

Brand name

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE

Generic name

NAPROXEN SODIUM

Active ingredients

DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM

Dosage form

TABLET

Route

ORAL

Marketing status

Discontinued

Sponsor

AMNEAL PHARMS CO

Manufacturer

Strategic Sourcing Services LLC

First approval

2018-10-23

Source

Authoritative

Drugs@FDA application overview

Machine

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