Product NDC: | 16590-622 |
Proprietary Name: | AMITIZA |
Non Proprietary Name: | LUBIPROSTONE |
Active Ingredient(s): | 8 ug/1 & nbsp; LUBIPROSTONE |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE, GELATIN COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 16590-622 |
Labeler Name: | STAT RX USA LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021908 |
Marketing Category: | NDA |
Start Marketing Date: | 20060131 |
Package NDC: | 16590-622-60 |
Package Description: | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (16590-622-60) |
NDC Code | 16590-622-60 |
Proprietary Name | AMITIZA |
Package Description | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (16590-622-60) |
Product NDC | 16590-622 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | LUBIPROSTONE |
Dosage Form Name | CAPSULE, GELATIN COATED |
Route Name | ORAL |
Start Marketing Date | 20060131 |
Marketing Category Name | NDA |
Labeler Name | STAT RX USA LLC |
Substance Name | LUBIPROSTONE |
Strength Number | 8 |
Strength Unit | ug/1 |
Pharmaceutical Classes | Chloride Channel Activator [EPC],Chloride Channel Activators [MoA] |