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Generated: November 14, 2018

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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. Five 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
Formulation / Manufacturing:see details
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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;TOPICALStrength0.2MG/VIAL
Approval Date:Feb 7, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 7, 2019
Regulatory Exclusivity Use:AN ADJUNCT TO AB EXTERNO GLAUCOMA SURGERY
Patent:➤ Sign UpPatent Expiration:Feb 1, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jul 19, 2026Product Flag?YSubstance Flag?Delist Request?

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