Details for New Drug Application (NDA): 213555
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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 213555
Tradename: | URSODIOL |
Applicant: | Chartwell Rx |
Ingredient: | ursodiol |
Patents: | 0 |
Suppliers and Packaging for NDA: 213555
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
URSODIOL | ursodiol | CAPSULE;ORAL | 213555 | ANDA | Chartwell RX, LLC | 62135-430 | 62135-430-60 | 60 CAPSULE in 1 BOTTLE (62135-430-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
Approval Date: | Aug 17, 2020 | TE: | AB | RLD: | No |
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