Assyro AI

Orange Book product · Generic (ANDA)

CYTARABINE

CYTARABINE

Generic (ANDA)ANDA 075383TE APRX HOSPIRA

At a glance

Nov 22, 1999

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 22, 1999

    27 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

CYTARABINE

Strength

100MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 075383

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CYTARABINE

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.