← FDA Drug Approvals (Drugs@FDA)

PAROXETINE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PRINSTON INC · Approved 2014-10-31

Drug application

FDA Application #
ANDA203854
Application type
Abbreviated New Drug Application (Generic)
Brand name
PAROXETINE
Generic name
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active ingredients
PAROXETINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
PRINSTON INC
Manufacturer
Solco Healthcare US, LLC
First approval
2014-10-31

Source

Authoritative
Drugs@FDA application overview
Machine
JSON-LD · Markdown