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BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: RHODES PHARMS · Approved 2020-11-05

Drug application

FDA Application #
ANDA202955
Application type
Abbreviated New Drug Application (Generic)
Brand name
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Generic name
Brompheniramine Maleate
Active ingredients
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage form
SYRUP
Route
ORAL
Marketing status
Discontinued
Sponsor
RHODES PHARMS
First approval
2020-11-05

Source

Authoritative
Drugs@FDA application overview
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