Details for New Drug Application (NDA): 021265
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NDA 021265 describes INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), which is a drug marketed by Sandoz Canada Inc and is included in one NDA. It is available from one supplier. Additional details are available on the INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) profile page.
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.
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 | 54643-5646-1 | 1 KIT in 1 CARTON (54643-5646-1) * 4 mL in 1 VIAL (54643-5648-1) * 1 mL in 1 VIAL (54643-5651-1) |
| 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 | 54643-5647 | 54643-5647-0 | 1 KIT in 1 CARTON (54643-5647-0) * 40 mL in 1 VIAL (54643-5653-0) * 10 mL in 1 VIAL (54643-5655-0) |
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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