Product NDC: | 67386-601 |
Proprietary Name: | Peganone |
Non Proprietary Name: | ethotoin |
Active Ingredient(s): | 250 mg/1 & nbsp; ethotoin |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 67386-601 |
Labeler Name: | Lundbeck Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA010841 |
Marketing Category: | NDA |
Start Marketing Date: | 19570422 |
Package NDC: | 67386-601-01 |
Package Description: | 100 TABLET in 1 BOTTLE (67386-601-01) |
NDC Code | 67386-601-01 |
Proprietary Name | Peganone |
Package Description | 100 TABLET in 1 BOTTLE (67386-601-01) |
Product NDC | 67386-601 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | ethotoin |
Dosage Form Name | TABLET |
Route Name | ORAL |
Start Marketing Date | 19570422 |
Marketing Category Name | NDA |
Labeler Name | Lundbeck Inc. |
Substance Name | ETHOTOIN |
Strength Number | 250 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |