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: | 58914-501-42 |
Package Description: | 42 SUPPOSITORY in 1 BOX (58914-501-42) |
NDC Code | 58914-501-42 |
Proprietary Name | CANASA |
Package Description | 42 SUPPOSITORY in 1 BOX (58914-501-42) |
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] |