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PAROXETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CADILA PHARMS LTD · Approved 2021-08-27

Drug application

FDA Application #
ANDA212645
Application type
Abbreviated New Drug Application (Generic)
Brand name
PAROXETINE HYDROCHLORIDE
Generic name
PAROXETINE
Active ingredients
PAROXETINE HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
CADILA PHARMS LTD
Manufacturer
Modavar Pharmaceuticals LLC
First approval
2021-08-27

Source

Authoritative
Drugs@FDA application overview
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