Product NDC: | 0149-0783 |
Proprietary Name: | Asacol HD |
Non Proprietary Name: | mesalamine |
Active Ingredient(s): | 800 mg/1 & nbsp; mesalamine |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, DELAYED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0149-0783 |
Labeler Name: | Procter & Gamble Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021830 |
Marketing Category: | NDA |
Start Marketing Date: | 20090528 |
Package NDC: | 0149-0783-01 |
Package Description: | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (0149-0783-01) |
NDC Code | 0149-0783-01 |
Proprietary Name | Asacol HD |
Package Description | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (0149-0783-01) |
Product NDC | 0149-0783 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | mesalamine |
Dosage Form Name | TABLET, DELAYED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20090528 |
Marketing Category Name | NDA |
Labeler Name | Procter & Gamble Pharmaceuticals, Inc. |
Substance Name | MESALAMINE |
Strength Number | 800 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] |