Assyro AI

Orange Book product · Generic (ANDA)

PACLITAXEL

PACLITAXEL

Generic (ANDA)ANDA 077574TE APRX FRESENIUS KABI USA

At a glance

Nov 27, 2006

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 27, 2006

    19 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

PACLITAXEL

Strength

6MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 077574

Product number

001

Marketing status

RX

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.