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ISOSULFAN BLUE

ANDA

ISOSULFAN BLUE | A210558 | SOMERSET THERAPEUTICS LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain8 active DMFs1 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

MYLAN PHARMACEUTICALS INC A VIATRIS COISOSULFAN BLUE

DMF 218832008

APITORIA PHARMA PRIVATE LTDISOSULFAN BLUE

DMF 277952013

BIOPHORE INDIA PHARMACEUTICALS PVT LTDISOSULFAN BLUE

DMF 298292015

DISHMAN CARBOGEN AMCIS LTDISOSULFAN BLUE

DMF 312262016

EMCURE PHARMACEUTICALS LTDISOSULFAN BLUE

DMF 331992018

MSN LABORATORIES PRIVATE LTDISOSULFAN BLUE

DMF 347172020

AGNO PHARMAISOSULFAN BLUE

DMF 349752020

SUVEN PHARMACEUTICALS LTDISOSULFAN BLUE

DMF 372582022

SAFC PHARMAInactiveISOSULFAN BLUE

DMF 208912007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 50MG/5ML (10MG/ML)

0 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Jul 12, 2019

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDtype7/1/2026

Somerset Therapeutics reactivated Isosulfan Blue (isosulfan blue) from discontinued status to active prescription drug status for NDA 210558.

Old: DISCN

New: RX

MODIFIEDTE Code7/1/2026

Somerset Therapeutics' Isosulfan Blue (isosulfan blue) received a therapeutic equivalence rating of AP, indicating it is not bioequivalent to the listed reference product.

New: AP