Assyro AI

Orange Book product · Generic (ANDA)

CARMUSTINE

CARMUSTINE

Generic (ANDA)ANDA 210179TE APRX NAVINTA LLC

At a glance

Sep 11, 2018

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 11, 2018

    7 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CARMUSTINE

Strength

100MG/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 210179

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.