Product NDC: | 63323-403 |
Proprietary Name: | Fosphenytoin |
Non Proprietary Name: | FOSPHENYTOIN SODIUM |
Active Ingredient(s): | 50 mg/mL & nbsp; FOSPHENYTOIN SODIUM |
Administration Route(s): | INTRAMUSCULAR; INTRAVENOUS |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 63323-403 |
Labeler Name: | APP Pharmaceuticals, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA078052 |
Marketing Category: | ANDA |
Start Marketing Date: | 20091214 |
Package NDC: | 63323-403-02 |
Package Description: | 25 VIAL in 1 TRAY (63323-403-02) > 2 mL in 1 VIAL |
NDC Code | 63323-403-02 |
Proprietary Name | Fosphenytoin |
Package Description | 25 VIAL in 1 TRAY (63323-403-02) > 2 mL in 1 VIAL |
Product NDC | 63323-403 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | FOSPHENYTOIN SODIUM |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | INTRAMUSCULAR; INTRAVENOUS |
Start Marketing Date | 20091214 |
Marketing Category Name | ANDA |
Labeler Name | APP Pharmaceuticals, LLC |
Substance Name | FOSPHENYTOIN SODIUM |
Strength Number | 50 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |