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GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: L PERRIGO CO · Approved 2022-02-01

Drug application

FDA Application #
ANDA214407
Application type
Abbreviated New Drug Application (Generic)
Brand name
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
Generic name
GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
Active ingredients
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Over-the-counter
Sponsor
L PERRIGO CO
Manufacturer
Cardinal Health 110, LLC. dba Leader
First approval
2022-02-01

Source

Authoritative
Drugs@FDA application overview
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