| Product NDC: | 50458-490 |
| Proprietary Name: | RAZADYNE |
| Non Proprietary Name: | galantamine hydrobromide |
| Active Ingredient(s): | 4 mg/mL & nbsp; galantamine hydrobromide |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 50458-490 |
| Labeler Name: | Janssen Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021224 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20010622 |
| Package NDC: | 50458-490-10 |
| Package Description: | 100 mL in 1 BOTTLE (50458-490-10) |
| NDC Code | 50458-490-10 |
| Proprietary Name | RAZADYNE |
| Package Description | 100 mL in 1 BOTTLE (50458-490-10) |
| Product NDC | 50458-490 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | galantamine hydrobromide |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 20010622 |
| Marketing Category Name | NDA |
| Labeler Name | Janssen Pharmaceuticals, Inc. |
| Substance Name | GALANTAMINE HYDROBROMIDE |
| Strength Number | 4 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA] |