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BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIBROW HLTHCARE · Approved 2020-06-16

Drug application

FDA Application #
ANDA211170
Application type
Abbreviated New Drug Application (Generic)
Brand name
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Generic name
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE,
Active ingredients
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage form
SYRUP
Route
ORAL
Marketing status
Prescription
Sponsor
HIBROW HLTHCARE
Manufacturer
Eywa Pharma Inc
First approval
2020-06-16

Source

Authoritative
Drugs@FDA application overview
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