Details for New Drug Application (NDA): 216732
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NDA 216732 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 216732
| Tradename: | MITOMYCIN |
| Applicant: | Eugia Pharma |
| Ingredient: | mitomycin |
| Patents: | 0 |
Pharmacology for NDA: 216732
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 216732
Suppliers and Packaging for NDA: 216732
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 216732 | ANDA | Eugia US LLC | 55150-450 | 55150-450-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-450-01) / 10 mL in 1 VIAL, SINGLE-DOSE |
| MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 216732 | ANDA | Eugia US LLC | 55150-451 | 55150-451-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-451-01) / 40 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/VIAL | ||||
| Approval Date: | Oct 30, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/VIAL | ||||
| Approval Date: | Oct 30, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 40MG/VIAL | ||||
| Approval Date: | Oct 30, 2023 | TE: | AP | RLD: | No | ||||
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