Active ingredient
Iso-Sulfan Blue
9 finished FDA listings contain Iso-Sulfan Blue as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ISOSULFAN BLUE
- Dosage forms
- Injection, Solution
- Routes
- Subcutaneous
- Manufacturers / labelers
- 6
- Strengths listed
- 10 mg/ml · 50 mg/5ml
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 27863
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 090874 | MYLAN INSTITUTIONAL | 2010-07-20 | 3 |
| ANDA 206831 | EUGIA PHARMA | 2016-02-02 | 2 |
| ANDA 210714 | SABA ILAY SANAYI | 2019-01-16 | 1 |
| ANDA 210558 | SOMERSET THERAPS LLC | 2019-07-12 | 1 |
| ANDA 213130 | MEITHEAL | 2021-11-03 | 1 |
| ANDA 216090 | MSN | 2022-09-16 | 1 |
Official labeling on DailyMed
- ISOSULFAN BLUE INJECTION, SOLUTION [DEVATIS, INC.] · version 2 · 2026-07-03
- ISOSULFAN BLUE INJECTION, SOLUTION [NOVADOZ PHARMACEUTICALS LLC] · version 2 · 2026-06-30
- ISOSULFAN BLUE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC] · version 5 · 2026-06-30
- ISOSULFAN BLUE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 2 · 2026-05-25
- ISOSULFAN BLUE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 9 · 2026-05-21
- ISOSULFAN BLUE INJECTION, SOLUTION [EUGIA US LLC] · version 5 · 2026-02-24
- ISOSULFAN BLUE INJECTION, SOLUTION [EUGIA US LLC] · version 3 · 2024-12-18
- ISOSULFAN BLUE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] · version 4 · 2021-11-08
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.