Assyro AI

Orange Book product · Generic (ANDA)

POLYMYXIN B SULFATE

POLYMYXIN B SULFATE

Generic (ANDA)ANDA 060716DISCN HIKMA

At a glance

Approved Prior to Jan 1, 1982

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

No patent or exclusivity dates are listed for this product.

Pharmaceutical detail

Active ingredient

POLYMYXIN B SULFATE

Strength

EQ 500,000 UNITS BASE/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 060716

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.