Product NDC: | 52584-317 |
Proprietary Name: | Phenytoin Sodium |
Non Proprietary Name: | Phenytoin Sodium |
Active Ingredient(s): | 50 mg/mL & nbsp; Phenytoin Sodium |
Administration Route(s): | INTRAMUSCULAR; INTRAVENOUS |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 52584-317 |
Labeler Name: | General Injectables & Vaccines, Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA089521 |
Marketing Category: | ANDA |
Start Marketing Date: | 20100801 |
Package NDC: | 52584-317-01 |
Package Description: | 1 AMPULE in 1 BAG (52584-317-01) > 2 mL in 1 AMPULE |
NDC Code | 52584-317-01 |
Proprietary Name | Phenytoin Sodium |
Package Description | 1 AMPULE in 1 BAG (52584-317-01) > 2 mL in 1 AMPULE |
Product NDC | 52584-317 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Phenytoin Sodium |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | INTRAMUSCULAR; INTRAVENOUS |
Start Marketing Date | 20100801 |
Marketing Category Name | ANDA |
Labeler Name | General Injectables & Vaccines, Inc |
Substance Name | PHENYTOIN SODIUM |
Strength Number | 50 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |