Dutasteride

Product NDC

0591-2292

11-digit product format

005912292

Labeler code

0591

Product ID

0591-2292_8ab949b3-4db5-47f5-909c-dd0e6a34432c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Dutasteride

Dosage form

CAPSULE

Route

ORAL

Labeler

Actavis Pharma, Inc.

Application

ANDA202808

Marketing category

ANDA

Marketing start

2015-11-20

Marketing end

2019-05-31

Substance

DUTASTERIDE

Active strength

1 mg/1

Pharmacologic classes

5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record