Product NDC: | 54092-476 |
Proprietary Name: | Lialda |
Non Proprietary Name: | mesalamine |
Active Ingredient(s): | 1.2 g/1 & nbsp; mesalamine |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, DELAYED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 54092-476 |
Labeler Name: | Shire US Manufacturing Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022000 |
Marketing Category: | NDA |
Start Marketing Date: | 20070116 |
Package NDC: | 54092-476-12 |
Package Description: | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-12) |
NDC Code | 54092-476-12 |
Proprietary Name | Lialda |
Package Description | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-12) |
Product NDC | 54092-476 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | mesalamine |
Dosage Form Name | TABLET, DELAYED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20070116 |
Marketing Category Name | NDA |
Labeler Name | Shire US Manufacturing Inc. |
Substance Name | MESALAMINE |
Strength Number | 1.2 |
Strength Unit | g/1 |
Pharmaceutical Classes | Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] |