| Product NDC: | 58914-501 |
| Proprietary Name: | CANASA |
| Non Proprietary Name: | Mesalamine |
| Active Ingredient(s): | 1000 mg/1 & nbsp; Mesalamine |
| Administration Route(s): | RECTAL |
| Dosage Form(s): | SUPPOSITORY |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 58914-501 |
| Labeler Name: | Aptalis Pharma US, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021252 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20010105 |
| Package NDC: | 58914-501-33 |
| Package Description: | 3 SUPPOSITORY in 1 BOX (58914-501-33) |
| NDC Code | 58914-501-33 |
| Proprietary Name | CANASA |
| Package Description | 3 SUPPOSITORY in 1 BOX (58914-501-33) |
| Product NDC | 58914-501 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Mesalamine |
| Dosage Form Name | SUPPOSITORY |
| Route Name | RECTAL |
| Start Marketing Date | 20010105 |
| Marketing Category Name | NDA |
| Labeler Name | Aptalis Pharma US, Inc. |
| Substance Name | MESALAMINE |
| Strength Number | 1000 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] |