Details for New Drug Application (NDA): 022572
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NDA 022572 describes MITOSOL, which is a drug marketed by Mobius Therap and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the MITOSOL profile page.
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.
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: | ⤷ Sign Up | Patent Expiration: | Feb 1, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 19, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 19, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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