Assyro AI

Orange Book product · Generic (ANDA)

GENTAMICIN SULFATE

GENTAMICIN SULFATE

Generic (ANDA)ANDA 062366TE APRX FRESENIUS KABI USA

At a glance

Aug 04, 1983

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 04, 1983

    43 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GENTAMICIN SULFATE

Strength

EQ 40MG BASE/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 062366

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.