| 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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