Paroxetine

Product NDC

51079-774

11-digit product format

510790774

Labeler code

51079

Product ID

51079-774_9af1694b-924e-831b-e053-2995a90a74f6

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

paroxetine hydrochloride hemihydrate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Mylan Institutional Inc.

Application

ANDA078902

Marketing category

ANDA

Marketing start

2005-12-26

Marketing end

2020-10-31

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

0000-00-00

Current FDA listing

Historical FDA.report record