| Product NDC: | 0115-1121 |
| Proprietary Name: | GALANTAMINE HYDROBROMIDE |
| Non Proprietary Name: | GALANTAMINE HYDROBROMIDE |
| Active Ingredient(s): | 16 mg/1 & nbsp; GALANTAMINE HYDROBROMIDE |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0115-1121 |
| Labeler Name: | Global Pharmaceuticals, Division of Impax Laboratories Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA078484 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20090527 |
| Package NDC: | 0115-1121-10 |
| Package Description: | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1121-10) |
| NDC Code | 0115-1121-10 |
| Proprietary Name | GALANTAMINE HYDROBROMIDE |
| Package Description | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1121-10) |
| Product NDC | 0115-1121 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | GALANTAMINE HYDROBROMIDE |
| Dosage Form Name | CAPSULE, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20090527 |
| Marketing Category Name | ANDA |
| Labeler Name | Global Pharmaceuticals, Division of Impax Laboratories Inc. |
| Substance Name | GALANTAMINE HYDROBROMIDE |
| Strength Number | 16 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] |