Assyro AI

Orange Book product · Generic (ANDA)

CARMUSTINE

CARMUSTINE

Generic (ANDA)ANDA 209278TE APRX PENN LIFE

At a glance

Apr 02, 2019

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 02, 2019

    7 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CARMUSTINE

Strength

100MG/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 209278

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CARMUSTINE

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.