Assyro AI

Orange Book product · Generic (ANDA)

GENTAMICIN SULFATE

GENTAMICIN SULFATE

Generic (ANDA)ANDA 065024RX FERA PHARMS LLC

At a glance

Jul 30, 2004

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 30, 2004

    22 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GENTAMICIN SULFATE

Strength

EQ 0.3% BASE

Dosage form

OINTMENT

Route

OPHTHALMIC

TE code

Not listed

Application

ANDA 065024

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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.