Details for New Drug Application (NDA): 206831
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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 206831
Tradename: | ISOSULFAN BLUE |
Applicant: | Eugia Pharma |
Ingredient: | isosulfan blue |
Patents: | 0 |
Suppliers and Packaging for NDA: 206831
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISOSULFAN BLUE | isosulfan blue | SOLUTION;SUBCUTANEOUS | 206831 | ANDA | AuroMedics Pharma LLC | 55150-240 | 55150-240-06 | 6 VIAL in 1 CARTON (55150-240-06) / 5 mL in 1 VIAL |
ISOSULFAN BLUE | isosulfan blue | SOLUTION;SUBCUTANEOUS | 206831 | ANDA | AuroMedics Pharma LLC | 55150-240 | 55150-240-05 | 6 VIAL in 1 CARTON (55150-240-05) / 5 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 50MG/5ML (10MG/ML) | ||||
Approval Date: | Feb 2, 2016 | TE: | RLD: | No |
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