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DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2014-02-26

Drug application

FDA Application #

ANDA202509

Application type

Abbreviated New Drug Application (Generic)

Brand name

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

Generic name

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

Active ingredients

DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

PH HEALTH

Manufacturer

Endo USA, Inc.

First approval

2014-02-26

Source

Authoritative

Drugs@FDA application overview

Machine

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