Paroxetine

Product NDC

35356-892

11-digit product format

353560892

Labeler code

35356

Product ID

35356-892_a2caab72-4627-4463-a25d-7bfdd8a9f92a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Paroxetine

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA078406

Marketing category

ANDA

Marketing start

2009-12-03

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