Assyro AI

Orange Book product · Generic (ANDA)

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Generic (ANDA)ANDA 062818DISCN IPHARM

At a glance

Oct 11, 1988

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 11, 1988

    38 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Strength

0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

ANDA 062818

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of GRAMICIDIN; 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.