Product NDC: | 16590-349 |
Proprietary Name: | URSODIOL |
Non Proprietary Name: | URSODIOL |
Active Ingredient(s): | 300 mg/1 & nbsp; URSODIOL |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 16590-349 |
Labeler Name: | STAT RX USA LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA019594 |
Marketing Category: | NDA |
Start Marketing Date: | 19871231 |
Package NDC: | 16590-349-30 |
Package Description: | 30 CAPSULE in 1 BOTTLE (16590-349-30) |
NDC Code | 16590-349-30 |
Proprietary Name | URSODIOL |
Package Description | 30 CAPSULE in 1 BOTTLE (16590-349-30) |
Product NDC | 16590-349 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | URSODIOL |
Dosage Form Name | CAPSULE |
Route Name | ORAL |
Start Marketing Date | 19871231 |
Marketing Category Name | NDA |
Labeler Name | STAT RX USA LLC |
Substance Name | URSODIOL |
Strength Number | 300 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] |