Product NDC: | 50458-387 |
Proprietary Name: | RAZADYNE |
Non Proprietary Name: | galantamine hydrobromide |
Active Ingredient(s): | 8 mg/1 & nbsp; galantamine hydrobromide |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 50458-387 |
Labeler Name: | Janssen Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021615 |
Marketing Category: | NDA |
Start Marketing Date: | 20041224 |
Package NDC: | 50458-387-30 |
Package Description: | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50458-387-30) |
NDC Code | 50458-387-30 |
Proprietary Name | RAZADYNE |
Package Description | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50458-387-30) |
Product NDC | 50458-387 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | galantamine hydrobromide |
Dosage Form Name | CAPSULE, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20041224 |
Marketing Category Name | NDA |
Labeler Name | Janssen Pharmaceuticals, Inc. |
Substance Name | GALANTAMINE HYDROBROMIDE |
Strength Number | 8 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] |