Irenka

Product NDC

27437-298

11-digit product format

274370298

Labeler code

27437

Product ID

27437-298_6a2c635d-32d1-4b42-b258-b0d83305ddd9

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Duloxetine

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Labeler

LUPIN PHARMA

Application

ANDA090694

Marketing category

ANDA

Marketing start

2015-06-01

Marketing end

0000-00-00

Substance

DULOXETINE HYDROCHLORIDE

Active strength

40 mg/1

Pharmacologic classes

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

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record