Product NDC: | 0430-0753 |
Proprietary Name: | Delzicol |
Non Proprietary Name: | mesalamine |
Active Ingredient(s): | 400 mg/1 & nbsp; mesalamine |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE, DELAYED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0430-0753 |
Labeler Name: | Warner Chilcott (US), LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA204412 |
Marketing Category: | NDA |
Start Marketing Date: | 20130301 |
Package NDC: | 0430-0753-27 |
Package Description: | 12 BOTTLE in 1 CASE (0430-0753-27) > 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE |
NDC Code | 0430-0753-27 |
Proprietary Name | Delzicol |
Package Description | 12 BOTTLE in 1 CASE (0430-0753-27) > 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE |
Product NDC | 0430-0753 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | mesalamine |
Dosage Form Name | CAPSULE, DELAYED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20130301 |
Marketing Category Name | NDA |
Labeler Name | Warner Chilcott (US), LLC |
Substance Name | MESALAMINE |
Strength Number | 400 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Aminosalicylate [EPC],Aminosalicylic Acids [Chemical/Ingredient] |