Details for New Drug Application (NDA): 205789
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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 205789
Tradename: | URSODIOL |
Applicant: | Lgm Pharma |
Ingredient: | ursodiol |
Patents: | 0 |
Suppliers and Packaging for NDA: 205789
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
URSODIOL | ursodiol | CAPSULE;ORAL | 205789 | ANDA | FH2 Pharma LLC | 72887-143 | 72887-143-06 | 60 CAPSULE in 1 BOTTLE (72887-143-06) |
URSODIOL | ursodiol | CAPSULE;ORAL | 205789 | ANDA | FH2 Pharma LLC | 72887-144 | 72887-144-06 | 60 CAPSULE in 1 BOTTLE (72887-144-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
Approval Date: | May 8, 2020 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 400MG | ||||
Approval Date: | May 8, 2020 | TE: | RLD: | No |
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