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DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AVANTHI INC · Approved 2013-02-27

Drug application

FDA Application #
ANDA078648
Application type
Abbreviated New Drug Application (Generic)
Brand name
DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE
Generic name
Dexbrompheniramine Maleate
Active ingredients
DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Discontinued
Sponsor
AVANTHI INC
First approval
2013-02-27

Source

Authoritative
Drugs@FDA application overview
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