Details for New Drug Application (NDA): 064144
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NDA 064144 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 064144
| Tradename: | MITOMYCIN |
| Applicant: | Accord Hlthcare |
| Ingredient: | mitomycin |
| Patents: | 0 |
Pharmacology for NDA: 064144
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 064144
Suppliers and Packaging for NDA: 064144
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 064144 | ANDA | Accord Healthcare, Inc. | 16729-108 | 16729-108-11 | 1 VIAL in 1 BOX, UNIT-DOSE (16729-108-11) / 40 mL in 1 VIAL |
| MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 064144 | ANDA | Accord Healthcare, Inc. | 16729-115 | 16729-115-05 | 1 VIAL in 1 CARTON (16729-115-05) / 10 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/VIAL | ||||
| Approval Date: | Apr 30, 1998 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/VIAL | ||||
| Approval Date: | Apr 30, 1998 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 40MG/VIAL | ||||
| Approval Date: | Aug 11, 2009 | TE: | AP | RLD: | No | ||||
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