Details for New Drug Application (NDA): 022572
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The generic ingredient in MITOSOL 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 022572
Tradename: | MITOSOL |
Applicant: | Mobius Therap |
Ingredient: | mitomycin |
Patents: | 5 |
Medical Subject Heading (MeSH) Categories for 022572
Suppliers and Packaging for NDA: 022572
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MITOSOL | mitomycin | FOR SOLUTION;TOPICAL | 022572 | NDA | Mobius Therapeutics LLC | 49771-002 | 49771-002-03 | 3 TRAY in 1 CARTON (49771-002-03) / 1 KIT in 1 TRAY (49771-002-01) * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 SYRINGE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;TOPICAL | Strength | 0.2MG/VIAL | ||||
Approval Date: | Feb 7, 2012 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Subscribe | Patent Expiration: | Feb 1, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Subscribe | Patent Expiration: | Jul 19, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Subscribe | Patent Expiration: | Jul 19, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? |
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