FDA Orange Book · active-ingredient family
Isosulfan blue
Isosulfan blue is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LYMPHAZURIN · NDA 018310
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LYMPHAZURINRLD | COVIDIEN | NDA 018310 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ISOSULFAN BLUE×3 | MYLAN INSTITUTIONAL | ANDA 090874 | — | Jan 28, 2026 | |
| ISOSULFAN BLUE | AM REGENT | ANDA 210294 | AP | May 17, 2023 | |
| ISOSULFAN BLUE | MSN | ANDA 216090 | AP | Sep 16, 2022 | |
| ISOSULFAN BLUE | FRESENIUS KABI USA | ANDA 211869 | — | Sep 08, 2022 | |
| ISOSULFAN BLUE | MEITHEAL | ANDA 213130 | AP | Nov 03, 2021 | |
| ISOSULFAN BLUE | SOMERSET THERAPS LLC | ANDA 210558 | AP | Jul 12, 2019 | |
| ISOSULFAN BLUE | SABA ILAY SANAYI | ANDA 210714 | — | Jan 16, 2019 | |
| ISOSULFAN BLUE | EUGIA PHARMA | ANDA 206831 | AP | Feb 02, 2016 |
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.
Isosulfan blue — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
