| Product NDC: | 39822-0615 |
| Proprietary Name: | Colistimethate |
| Non Proprietary Name: | Colistimethate |
| Active Ingredient(s): | 150 mg/1 & nbsp; Colistimethate |
| Administration Route(s): | INTRAMUSCULAR; INTRAVENOUS |
| Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 39822-0615 |
| Labeler Name: | X-GEN Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA064216 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20110101 |
| Package NDC: | 39822-0615-2 |
| Package Description: | 12 CARTON in 1 CARTON (39822-0615-2) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (39822-0615-1) |
| NDC Code | 39822-0615-2 |
| Proprietary Name | Colistimethate |
| Package Description | 12 CARTON in 1 CARTON (39822-0615-2) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (39822-0615-1) |
| Product NDC | 39822-0615 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Colistimethate |
| Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route Name | INTRAMUSCULAR; INTRAVENOUS |
| Start Marketing Date | 20110101 |
| Marketing Category Name | ANDA |
| Labeler Name | X-GEN Pharmaceuticals, Inc. |
| Substance Name | COLISTIMETHATE SODIUM |
| Strength Number | 150 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient] |