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LORATADINE AND PSEUDOEPHEDRINE SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DR REDDYS · Approved 2026-08-06

Drug application

FDA Application #
ANDA220448
Application type
Abbreviated New Drug Application (Generic)
Brand name
LORATADINE AND PSEUDOEPHEDRINE SULFATE
Generic name
Loratadine
Active ingredients
LORATADINE; PSEUDOEPHEDRINE SULFATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Over-the-counter
Sponsor
DR REDDYS
First approval
2026-08-06

Source

Authoritative
Drugs@FDA application overview
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