Assyro AI

Orange Book product · Generic (ANDA)

IRINOTECAN HYDROCHLORIDE

IRINOTECAN HYDROCHLORIDE

Generic (ANDA)ANDA 090101DISCN TEVA PHARMS USA

At a glance

Feb 27, 2008

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 27, 2008

    18 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

IRINOTECAN HYDROCHLORIDE

Strength

40MG/2ML (20MG/ML)

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 090101

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of IRINOTECAN HYDROCHLORIDE

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.