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Orange Book product · Generic (ANDA)

DUTASTERIDE

DUTASTERIDE

Generic (ANDA)ANDA 202808DISCN ACTAVIS LABS FL INC
View DUTASTERIDE familyOpen on FDA Orange Book

At a glance

Nov 20, 2015

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 20, 2015

    10 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DUTASTERIDE

Strength

0.5MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

ANDA 202808

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of DUTASTERIDE

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

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