Assyro AI

Orange Book product · Generic (ANDA)

ISOSULFAN BLUE

ISOSULFAN BLUE

Generic (ANDA)ANDA 210294TE APRX AM REGENT

At a glance

May 17, 2023

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 17, 2023

    3 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ISOSULFAN BLUE

Strength

50MG/5ML (10MG/ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

AP

Application

ANDA 210294

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ISOSULFAN BLUE

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.