Details for New Drug Application (NDA): 214504
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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.
Pharmacology for NDA: 214504
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 214504
Suppliers and Packaging for NDA: 214504
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 214504 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-139 | 71288-139-51 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-139-51) / 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: | Sep 6, 2022 | TE: | AP | RLD: | No |
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