Details for New Drug Application (NDA): 216648
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NDA 216648 describes MITOMYCIN, which is a drug marketed by Accord Hlthcare, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Meitheal, and Rk Pharma, and is included in twelve NDAs. It is available from ten suppliers. Additional details are available on the MITOMYCIN profile page.
The generic ingredient in MITOMYCIN is mitomycin. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the mitomycin profile page.
The generic ingredient in MITOMYCIN is mitomycin. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the mitomycin profile page.
Summary for 216648
| Tradename: | MITOMYCIN |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | mitomycin |
| Patents: | 0 |
Pharmacology for NDA: 216648
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 216648
Suppliers and Packaging for NDA: 216648
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 216648 | ANDA | Sagent Pharmaceuticals | 25021-252 | 25021-252-51 | 1 VIAL in 1 CARTON (25021-252-51) / 80 mL in 1 VIAL |
| MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 216648 | ANDA | Fresenius Kabi USA, LLC | 65219-568 | 65219-568-00 | 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-568-00) / 80 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 40MG/VIAL | ||||
| Approval Date: | Nov 22, 2022 | TE: | AP | RLD: | No | ||||
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