DUTASTERIDE

Product NDC

51991-749

11-digit product format

519910749

Labeler code

51991

Product ID

51991-749_c42380e0-6b30-4a92-8349-dd2941e90fcb

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

DUTASTERIDE

Dosage form

CAPSULE

Route

ORAL

Labeler

Breckenridge Pharmaceutical, Inc.

Application

ANDA204705

Marketing category

ANDA

Marketing start

2015-11-20

Marketing end

2019-08-31

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