Assyro AI

Orange Book product · Generic (ANDA)

GENTAMICIN SULFATE

GENTAMICIN SULFATE

Generic (ANDA)ANDA 064056TE ATRX COSETTE PHARMS NC

At a glance

Apr 29, 1994

Approved

Generic (ANDA)

Application

AT

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 29, 1994

    32 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GENTAMICIN SULFATE

Strength

EQ 0.1% BASE

Dosage form

CREAM

Route

TOPICAL

TE code

AT

Application

ANDA 064056

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of GENTAMICIN 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.