← FDA Drug Approvals (Drugs@FDA)

GUAIFENESIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS · Approved 2018-07-11

Drug application

FDA Application #

ANDA207342

Application type

Abbreviated New Drug Application (Generic)

Brand name

GUAIFENESIN

Generic name

GUAIFENESIN

Active ingredients

GUAIFENESIN

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Over-the-counter

Sponsor

AMNEAL PHARMS

Manufacturer

Care One (American Sales Company)

First approval

2018-07-11

Source

Authoritative

Drugs@FDA application overview

Machine

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