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: | 68220-022-28 |
Package Description: | 28 BOTTLE, WITH APPLICATOR in 1 CARTON (68220-022-28) > 60 mL in 1 BOTTLE, WITH APPLICATOR (68220-022-60) |
NDC Code | 68220-022-28 |
Proprietary Name | sF Rowasa |
Package Description | 28 BOTTLE, WITH APPLICATOR in 1 CARTON (68220-022-28) > 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] |