Paroxetine

Product NDC

70518-1210

11-digit product format

705181210

Labeler code

70518

Product ID

70518-1210_90aaedf3-b134-739b-e053-2a95a90a5753

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

paroxetine hydrochloride hemihydrate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

ANDA203854

Marketing category

ANDA

Marketing start

2018-05-16

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

2020-12-31

Current FDA listing

Historical FDA.report record