← FDA Drug Approvals (Drugs@FDA)

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PERRIGO R AND D · Approved 2018-03-05

Drug application

FDA Application #

ANDA207602

Application type

Abbreviated New Drug Application (Generic)

Brand name

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE

Generic name

DEXTROMETHORPHAN HBR, GUAIFENESIN

Active ingredients

DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Over-the-counter

Sponsor

PERRIGO R AND D

Manufacturer

HyVee Inc

First approval

2018-03-05

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown