Product NDC: | 0378-3750 |
Proprietary Name: | Phenytek |
Non Proprietary Name: | phenytoin sodium |
Active Ingredient(s): | 300 mg/1 & nbsp; phenytoin sodium |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0378-3750 |
Labeler Name: | Mylan Pharmaceuticals Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA040298 |
Marketing Category: | ANDA |
Start Marketing Date: | 20110707 |
Package NDC: | 0378-3750-01 |
Package Description: | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-3750-01) |
NDC Code | 0378-3750-01 |
Proprietary Name | Phenytek |
Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-3750-01) |
Product NDC | 0378-3750 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | phenytoin sodium |
Dosage Form Name | CAPSULE, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20110707 |
Marketing Category Name | ANDA |
Labeler Name | Mylan Pharmaceuticals Inc. |
Substance Name | PHENYTOIN SODIUM |
Strength Number | 300 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |