Details for New Drug Application (NDA): 202540
✉ 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 202540
Tradename: | URSODIOL |
Applicant: | Endo Operations |
Ingredient: | ursodiol |
Patents: | 0 |
Suppliers and Packaging for NDA: 202540
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
URSODIOL | ursodiol | TABLET;ORAL | 202540 | ANDA | Major Pharmaceuticals | 0904-6890 | 0904-6890-04 | 30 BLISTER PACK in 1 CARTON (0904-6890-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
URSODIOL | ursodiol | TABLET;ORAL | 202540 | ANDA | AvKARE | 42291-931 | 42291-931-01 | 100 TABLET, FILM COATED in 1 BOTTLE (42291-931-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Feb 14, 2013 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Feb 14, 2013 | TE: | AB | RLD: | No |
Complete Access Available with Subscription