Details for New Drug Application (NDA): 079184
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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 079184
Tradename: | URSODIOL |
Applicant: | Teva Pharms Usa |
Ingredient: | ursodiol |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | May 13, 2009 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | May 13, 2009 | TE: | RLD: | No |
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