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: | 0378-1730-05 |
Package Description: | 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-1730-05) |
NDC Code | 0378-1730-05 |
Proprietary Name | Ursodiol |
Package Description | 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-1730-05) |
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] |