Assyro AI

Orange Book product · Generic (ANDA)

POLYMYXIN B SULFATE

POLYMYXIN B SULFATE

Generic (ANDA)ANDA 062455DISCN PADDOCK LLC

At a glance

Jul 27, 1983

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 27, 1983

    43 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

POLYMYXIN B SULFATE

Strength

100,000,000 UNITS/BOT

Dosage form

POWDER

Route

FOR RX COMPOUNDING

TE code

Not listed

Application

ANDA 062455

Product number

001

Marketing status

DISCN

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.