Product NDC: | 49999-574 |
Proprietary Name: | PHENYTOIN SODIUM |
Non Proprietary Name: | PHENYTOIN SODIUM |
Active Ingredient(s): | 100 mg/1 & nbsp; PHENYTOIN SODIUM |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 49999-574 |
Labeler Name: | Lake Erie Medical DBA Quality Care Products LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA040621 |
Marketing Category: | ANDA |
Start Marketing Date: | 20061212 |
Package NDC: | 49999-574-60 |
Package Description: | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49999-574-60) |
NDC Code | 49999-574-60 |
Proprietary Name | PHENYTOIN SODIUM |
Package Description | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (49999-574-60) |
Product NDC | 49999-574 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | PHENYTOIN SODIUM |
Dosage Form Name | CAPSULE, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20061212 |
Marketing Category Name | ANDA |
Labeler Name | Lake Erie Medical DBA Quality Care Products LLC |
Substance Name | PHENYTOIN SODIUM |
Strength Number | 100 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |