Details for New Drug Application (NDA): 210558
✉ Email this page to a colleague
NDA 210558 describes ISOSULFAN BLUE, which is a drug marketed by Am Regent, Beloteca, Eugia Pharma, Fresenius Kabi Usa, Meitheal, MSN, Mylan Institutional, and Somerset Theraps Llc, and is included in eight NDAs. It is available from four suppliers. Additional details are available on the ISOSULFAN BLUE profile page.
The generic ingredient in ISOSULFAN BLUE is isosulfan blue. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the isosulfan blue profile page.
The generic ingredient in ISOSULFAN BLUE is isosulfan blue. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the isosulfan blue profile page.
Summary for 210558
| Tradename: | ISOSULFAN BLUE |
| Applicant: | Somerset Theraps Llc |
| Ingredient: | isosulfan blue |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210558
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ISOSULFAN BLUE | isosulfan blue | SOLUTION;SUBCUTANEOUS | 210558 | ANDA | Somerset Therapeutics, LLC | 70069-221 | 70069-221-06 | 6 VIAL in 1 CARTON (70069-221-06) / 5 mL in 1 VIAL (70069-221-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 50MG/5ML (10MG/ML) | ||||
| Approval Date: | Jul 12, 2019 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
