Details for New Drug Application (NDA): 214849
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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 214849
Tradename: | URSODIOL |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | ursodiol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 214849
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
URSODIOL | ursodiol | CAPSULE;ORAL | 214849 | ANDA | Aurobindo Pharma Limited | 59651-421 | 59651-421-01 | 100 CAPSULE in 1 BOTTLE (59651-421-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
Approval Date: | Nov 28, 2022 | TE: | AB | RLD: | No |
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