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GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS · Approved 2018-11-01

Drug application

FDA Application #

ANDA209692

Application type

Abbreviated New Drug Application (Generic)

Brand name

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE

Generic name

GUAIFENESIN, DEXTROMETHORPHAN HBR

Active ingredients

DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Over-the-counter

Sponsor

AMNEAL PHARMS

Manufacturer

Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

First approval

2018-11-01

Source

Authoritative

Drugs@FDA application overview

Machine

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