Details for New Drug Application (NDA): 200826
✉ Email this page to a colleague
The generic ingredient in URSODIOL is ursodiol. There are eight drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the ursodiol profile page.
Summary for 200826
Tradename: | URSODIOL |
Applicant: | Impax Labs Inc |
Ingredient: | ursodiol |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Dec 23, 2011 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Dec 23, 2011 | TE: | RLD: | No |
Complete Access Available with Subscription