Assyro AI

Orange Book product · Generic (ANDA)

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC

BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Generic (ANDA)ANDA 060764DISCN PADAGIS US

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

BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Strength

400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

Dosage form

OINTMENT

Route

OPHTHALMIC

TE code

Not listed

Application

ANDA 060764

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of BACITRACIN ZINC; NEOMYCIN SULFATE; 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.