Details for New Drug Application (NDA): 021265
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The generic ingredient in INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) is ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k profile page.
Summary for 021265
Pharmacology for NDA: 021265
Ingredient-type | Analogs/Derivatives Vitamin B 6 |
Physiological Effect | Increased Prothrombin Activity Reversed Anticoagulation Activity |
Suppliers and Packaging for NDA: 021265
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
INFUVITE PEDIATRIC | ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k | INJECTABLE;INTRAVENOUS | 021265 | NDA | Sandoz Inc | 54643-5646 | 54643-5646-0 | 2 VIAL in 1 CARTON (54643-5646-0) / 5 mL in 1 VIAL |
INFUVITE PEDIATRIC | ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k | INJECTABLE;INTRAVENOUS | 021265 | NDA | Sandoz Inc | 54643-5646 | 54643-5646-1 | 10 VIAL in 1 CARTON (54643-5646-1) / 5 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL | ||||
Approval Date: | Feb 21, 2001 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL | ||||
Approval Date: | Jan 29, 2004 | TE: | RLD: | Yes |
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