Details for New Drug Application (NDA): 202540
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The generic ingredient in URSODIOL is ursodiol. There are eight drug master file entries for this compound. Twenty-nine 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 |
Formulation / Manufacturing: | see details |
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 |
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