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Orange Book product · Generic (ANDA)

DECITABINE

DECITABINE

Generic (ANDA)ANDA 204607TE APRX PHARMASCIENCE INC
View DECITABINE familyOpen on FDA Orange Book

At a glance

May 31, 2017

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 31, 2017

    9 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DECITABINE

Strength

50MG/VIAL

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

AP

Application

ANDA 204607

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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