Details for New Drug Application (NDA): 213130
NDA 213130 describes ISOSULFAN BLUE, which is a drug marketed by Am Regent, Eugia Pharma, Fresenius Kabi Usa, Meitheal, MSN, Mylan Institutional, Saba Ilay Sanayi, and Somerset Theraps Llc, and is included in eight NDAs. It is available from six suppliers. Additional details are available on the ISOSULFAN BLUE profile page.
The generic ingredient in ISOSULFAN BLUE is isosulfan blue. There is one drug master file entry for this compound. Six 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 is one drug master file entry for this compound. Six 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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