Dutasteride and tamsulosin hydrochloride

Product NDC

0591-3771

11-digit product format

005913771

Labeler code

0591

Product ID

0591-3771_9cdbac0e-97f6-496c-885e-134a23bc3333

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Dutasteride and tamsulosin hydrochloride

Dosage form

CAPSULE

Route

ORAL

Labeler

Actavis Pharma, Inc.

Application

ANDA202975

Marketing category

ANDA

Marketing start

2016-04-13

Marketing end

0000-00-00

Substance

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

Active strength

1 mg/1; mg/1

Pharmacologic classes

5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA],Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record