 
                        | Product NDC: | 49771-002 | 
| Proprietary Name: | Mitosol | 
| Non Proprietary Name: | mitomycin | 
| Active Ingredient(s): | & nbsp; mitomycin | 
| Administration Route(s): | URETERAL | 
| Dosage Form(s): | KIT | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 49771-002 | 
| Labeler Name: | Mobius Therapeutics LLC | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | NDA022572 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 20120208 | 
| Package NDC: | 49771-002-03 | 
| Package Description: | 3 TRAY in 1 CARTON (49771-002-03) > 1 KIT in 1 TRAY (49771-002-01) * 1 mL in 1 SYRINGE * 1 APPLICATOR in 1 PACKET (53329-805-09) > 5 mL in 1 APPLICATOR * 1 mL in 1 VIAL, SINGLE-USE | 
| NDC Code | 49771-002-03 | 
| Proprietary Name | Mitosol | 
| Package Description | 3 TRAY in 1 CARTON (49771-002-03) > 1 KIT in 1 TRAY (49771-002-01) * 1 mL in 1 SYRINGE * 1 APPLICATOR in 1 PACKET (53329-805-09) > 5 mL in 1 APPLICATOR * 1 mL in 1 VIAL, SINGLE-USE | 
| Product NDC | 49771-002 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | mitomycin | 
| Dosage Form Name | KIT | 
| Route Name | URETERAL | 
| Start Marketing Date | 20120208 | 
| Marketing Category Name | NDA | 
| Labeler Name | Mobius Therapeutics LLC | 
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