| Product NDC: | 16729-108 |
| Proprietary Name: | Mitomycin |
| Non Proprietary Name: | Mitomycin |
| Active Ingredient(s): | 20 mg/40mL & nbsp; Mitomycin |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 16729-108 |
| Labeler Name: | Accord Healthcare Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA064144 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20090610 |
| Package NDC: | 16729-108-11 |
| Package Description: | 1 VIAL in 1 BOX, UNIT-DOSE (16729-108-11) > 40 mL in 1 VIAL |
| NDC Code | 16729-108-11 |
| Proprietary Name | Mitomycin |
| Package Description | 1 VIAL in 1 BOX, UNIT-DOSE (16729-108-11) > 40 mL in 1 VIAL |
| Product NDC | 16729-108 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Mitomycin |
| Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20090610 |
| Marketing Category Name | ANDA |
| Labeler Name | Accord Healthcare Inc |
| Substance Name | MITOMYCIN |
| Strength Number | 20 |
| Strength Unit | mg/40mL |
| Pharmaceutical Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |