| Product NDC: | 68220-022 |
| Proprietary Name: | sF Rowasa |
| Non Proprietary Name: | Mesalamine |
| Active Ingredient(s): | 4 g/60mL & nbsp; Mesalamine |
| Administration Route(s): | RECTAL |
| Dosage Form(s): | SUSPENSION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 68220-022 |
| Labeler Name: | Alaven Pharmaceutical LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA019618 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090901 |
| Package NDC: | 68220-022-01 |
| Package Description: | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (68220-022-01) > 60 mL in 1 BOTTLE, WITH APPLICATOR (68220-022-60) |
| NDC Code | 68220-022-01 |
| Proprietary Name | sF Rowasa |
| Package Description | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (68220-022-01) > 60 mL in 1 BOTTLE, WITH APPLICATOR (68220-022-60) |
| Product NDC | 68220-022 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Mesalamine |
| Dosage Form Name | SUSPENSION |
| Route Name | RECTAL |
| Start Marketing Date | 20090901 |
| Marketing Category Name | NDA |
| Labeler Name | Alaven Pharmaceutical LLC |
| Substance Name | MESALAMINE |
| Strength Number | 4 |
| Strength Unit | g/60mL |
| Pharmaceutical Classes | Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] |