Details for New Drug Application (NDA): 215687
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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.
Summary for 215687
Tradename: | MITOMYCIN |
Applicant: | Gland Pharma Ltd |
Ingredient: | mitomycin |
Patents: | 0 |
Pharmacology for NDA: 215687
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 215687
Suppliers and Packaging for NDA: 215687
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 215687 | ANDA | Sagent Pharmaceuticals | 25021-250 | 25021-250-20 | 1 VIAL in 1 CARTON (25021-250-20) / 10 mL in 1 VIAL |
MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 215687 | ANDA | Sagent Pharmaceuticals | 25021-251 | 25021-251-50 | 1 VIAL in 1 CARTON (25021-251-50) / 40 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/VIAL | ||||
Approval Date: | Oct 20, 2021 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/VIAL | ||||
Approval Date: | Oct 20, 2021 | TE: | AP | RLD: | No |
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