Assyro AI

Orange Book product · Generic (ANDA)

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN

GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Generic (ANDA)ANDA 064047TE ATRX BAUSCH AND LOMB INC

At a glance

Jan 31, 1996

Approved

Generic (ANDA)

Application

AT

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 31, 1996

    30 yr 10 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

AT

Application

ANDA 064047

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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.