Assyro AI

Orange Book product · Generic (ANDA)

GENTAMICIN SULFATE

GENTAMICIN SULFATE

Generic (ANDA)ANDA 062251TE APRX HIKMA

At a glance

Approved Prior to Jan 1, 1982

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

No patent or exclusivity dates are listed for this product.

Pharmaceutical detail

Active ingredient

GENTAMICIN SULFATE

Strength

EQ 10MG BASE/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 062251

Product number

002

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.