Details for New Drug Application (NDA): 202670
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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: 202670
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 202670
Suppliers and Packaging for NDA: 202670
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 202670 | ANDA | Archis Pharma LLC | 72819-152 | 72819-152-95 | 1 VIAL in 1 CARTON (72819-152-95) / 10 mL in 1 VIAL |
MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 202670 | ANDA | Archis Pharma LLC | 72819-152 | 72819-152-05 | 1 VIAL in 1 CARTON (72819-152-05) / 10 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/VIAL | ||||
Approval Date: | Oct 13, 2017 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/VIAL | ||||
Approval Date: | Oct 13, 2017 | TE: | AP | RLD: | No |
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