Paroxetine

Product NDC

57664-425

11-digit product format

576640425

Labeler code

57664

Product ID

57664-425_38e34831-580e-4773-a1a8-7358fee2424e

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Paroxetine

Dosage form

TABLET

Route

ORAL

Labeler

Sun Pharmaceutical Industries, Inc.

Application

ANDA078194

Marketing category

ANDA

Marketing start

2007-06-29

Marketing end

0000-00-00

Substance

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Active strength

40 mg/1

Pharmacologic classes

Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record