Paroxetine

Product NDC

43063-170

11-digit product format

430630170

Labeler code

43063

Product ID

43063-170_7d3acc64-a4f4-5d79-e053-2991aa0afe03

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

paroxetine hydrochloride hemihydrate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

PD-Rx Pharmaceuticals, Inc.

Application

ANDA078902

Marketing category

ANDA

Marketing start

2008-03-24

Marketing end

0000-00-00

Substance

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Active strength

20 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