Details for New Drug Application (NDA): 213504
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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 213504
Tradename: | URSODIOL |
Applicant: | Strides Pharma |
Ingredient: | ursodiol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 213504
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
URSODIOL | ursodiol | TABLET;ORAL | 213504 | ANDA | Strides Pharma Science Limited | 64380-918 | 64380-918-06 | 100 TABLET in 1 BOTTLE (64380-918-06) |
URSODIOL | ursodiol | TABLET;ORAL | 213504 | ANDA | Strides Pharma Science Limited | 64380-919 | 64380-919-06 | 100 TABLET in 1 BOTTLE (64380-919-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Aug 20, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Aug 20, 2020 | TE: | AB | RLD: | No |
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