Details for New Drug Application (NDA): 021163
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NDA 021163 describes INFUVITE ADULT, 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 ADULT profile page.
The generic ingredient in INFUVITE ADULT is alpha-tocopherol acetate; ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a palmitate; vitamin k. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the alpha-tocopherol acetate; ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a palmitate; vitamin k profile page.
The generic ingredient in INFUVITE ADULT is alpha-tocopherol acetate; ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a palmitate; vitamin k. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the alpha-tocopherol acetate; ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a palmitate; vitamin k profile page.
Summary for 021163
Pharmacology for NDA: 021163
| Ingredient-type | Analogs/Derivatives Vitamin B 6 |
| Physiological Effect | Increased Prothrombin Activity Reversed Anticoagulation Activity |
Suppliers and Packaging for NDA: 021163
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INFUVITE ADULT | alpha-tocopherol acetate; ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a palmitate; vitamin k | SOLUTION;INTRAVENOUS | 021163 | NDA | Sandoz Inc | 54643-5649 | 54643-5649-1 | 10 VIAL in 1 CARTON (54643-5649-1) / 5 mL in 1 VIAL |
| INFUVITE ADULT | alpha-tocopherol acetate; ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a palmitate; vitamin k | SOLUTION;INTRAVENOUS | 021163 | NDA | Sandoz Inc | 54643-7862 | 54643-7862-1 | 10 VIAL in 1 CARTON (54643-7862-1) / 5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML | ||||
| Approval Date: | May 18, 2000 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML | ||||
| Approval Date: | Jun 16, 2003 | TE: | RLD: | Yes | |||||
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