Paroxetine

Product NDC

59746-457

11-digit product format

597460457

Labeler code

59746

Product ID

59746-457_304e02c2-48d3-4f9e-a7de-8d9be564580b

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

paroxetine hydrochloride hemihydrate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Jubilant Cadista Pharmaceuticals Inc.

Application

ANDA205528

Marketing category

ANDA

Marketing start

2015-11-20

Marketing end

0000-00-00

Substance

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Active strength

10 mg/1

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record