Assyro AI

Orange Book product · Generic (ANDA)

TOBRAMYCIN SULFATE

TOBRAMYCIN SULFATE

Generic (ANDA)ANDA 065122TE APRX FRESENIUS KABI USA

At a glance

Nov 29, 2002

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 29, 2002

    23 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TOBRAMYCIN SULFATE

Strength

EQ 10MG BASE/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 065122

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of TOBRAMYCIN 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.