Details for New Drug Application (NDA): 090801
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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 090801
Tradename: | URSODIOL |
Applicant: | Glenmark Generics |
Ingredient: | ursodiol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 090801
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
URSODIOL | ursodiol | TABLET;ORAL | 090801 | ANDA | BluePoint Laboratories | 68001-377 | 68001-377-00 | 100 TABLET in 1 BOTTLE (68001-377-00) |
URSODIOL | ursodiol | TABLET;ORAL | 090801 | ANDA | BluePoint Laboratories | 68001-378 | 68001-378-00 | 100 TABLET in 1 BOTTLE (68001-378-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Jul 12, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Jul 12, 2011 | TE: | AB | RLD: | No |
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