Details for New Drug Application (NDA): 213130
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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 213130
Tradename: | ISOSULFAN BLUE |
Applicant: | Meitheal |
Ingredient: | isosulfan blue |
Patents: | 0 |
Suppliers and Packaging for NDA: 213130
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ISOSULFAN BLUE | isosulfan blue | SOLUTION;SUBCUTANEOUS | 213130 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-805 | 71288-805-06 | 6 VIAL, SINGLE-DOSE in 1 CARTON (71288-805-06) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-805-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 50MG/5ML (10MG/ML) | ||||
Approval Date: | Nov 3, 2021 | TE: | AP | RLD: | No |
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