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Orange Book product · Generic (ANDA)

PACLITAXEL

PACLITAXEL

Generic (ANDA)ANDA 091540DISCN NATCO PHARMA USA

At a glance

Sep 29, 2011

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 29, 2011

    14 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PACLITAXEL

Strength

6MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 091540

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of PACLITAXEL

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.