Orange Book product · Brand (NDA)
LYMPHAZURIN
ISOSULFAN BLUE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
ISOSULFAN BLUE
Strength
50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 018310
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2026ISOSULFAN BLUEGeneric (ANDA)
ANDA 090874 · MYLAN INSTITUTIONAL
- 2023ISOSULFAN BLUEGeneric (ANDA)
ANDA 210294 · AM REGENT
- 2022ISOSULFAN BLUEGeneric (ANDA)
ANDA 216090 · MSN
- 2022ISOSULFAN BLUEGeneric (ANDA)
ANDA 211869 · FRESENIUS KABI USA
- 2021ISOSULFAN BLUEGeneric (ANDA)
ANDA 213130 · MEITHEAL
- 2019ISOSULFAN BLUEGeneric (ANDA)
ANDA 210558 · SOMERSET THERAPS LLC
- 2019ISOSULFAN BLUEGeneric (ANDA)
ANDA 210714 · SABA ILAY SANAYI
- 2016ISOSULFAN BLUEGeneric (ANDA)
ANDA 206831 · EUGIA PHARMA
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.
