| Product NDC: | 0378-1730 |
| 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: | 0378-1730 |
| Labeler Name: | Mylan Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA090530 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120507 |
| Package NDC: | 0378-1730-01 |
| Package Description: | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1730-01) |
| NDC Code | 0378-1730-01 |
| Proprietary Name | Ursodiol |
| Package Description | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1730-01) |
| Product NDC | 0378-1730 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | ursodiol |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 20120507 |
| Marketing Category Name | ANDA |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | URSODIOL |
| Strength Number | 300 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Bile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient] |