Product NDC: | 16729-115 |
Proprietary Name: | Mitomycin |
Non Proprietary Name: | Mitomycin |
Active Ingredient(s): | 5 mg/10mL & nbsp; Mitomycin |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 16729-115 |
Labeler Name: | Accord Healthcare Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA064144 |
Marketing Category: | ANDA |
Start Marketing Date: | 20090618 |
Package NDC: | 16729-115-05 |
Package Description: | 1 VIAL in 1 CARTON (16729-115-05) > 10 mL in 1 VIAL |
NDC Code | 16729-115-05 |
Proprietary Name | Mitomycin |
Package Description | 1 VIAL in 1 CARTON (16729-115-05) > 10 mL in 1 VIAL |
Product NDC | 16729-115 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Mitomycin |
Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20090618 |
Marketing Category Name | ANDA |
Labeler Name | Accord Healthcare Inc |
Substance Name | MITOMYCIN |
Strength Number | 5 |
Strength Unit | mg/10mL |
Pharmaceutical Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |