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LORATADINE AND PSEUDOEPHEDRINE SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PERRIGO PHARMA INTL · Approved 2003-01-30

Drug application

FDA Application #
ANDA076050
Application type
Abbreviated New Drug Application (Generic)
Brand name
LORATADINE AND PSEUDOEPHEDRINE SULFATE
Generic name
LORATADINE, PSEUDOEPHEDRINE SULFATE
Active ingredients
LORATADINE; PSEUDOEPHEDRINE SULFATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Over-the-counter
Sponsor
PERRIGO PHARMA INTL
Manufacturer
L. Perrigo Company
First approval
2003-01-30

Source

Authoritative
Drugs@FDA application overview
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