Details for New Drug Application (NDA): 210558
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The generic ingredient in ISOSULFAN BLUE is isosulfan blue. There are six drug master file entries for this compound. Five 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 |
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