Assyro AI

Orange Book product · Generic (ANDA)

POLYMYXIN B SULFATE

POLYMYXIN B SULFATE

Generic (ANDA)ANDA 065372TE APRX FRESENIUS KABI USA

At a glance

Jan 10, 2008

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 10, 2008

    18 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

POLYMYXIN B SULFATE

Strength

EQ 500,000 UNITS BASE/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 065372

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of POLYMYXIN B SULFATE

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.