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Orange Book product · Generic (ANDA)

DECITABINE

DECITABINE

Generic (ANDA)ANDA 209056TE APRX WOCKHARDT BIO AG
View DECITABINE familyOpen on FDA Orange Book

At a glance

Apr 09, 2019

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 09, 2019

    7 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DECITABINE

Strength

50MG/VIAL

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

AP

Application

ANDA 209056

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of DECITABINE

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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