Details for New Drug Application (NDA): 214980
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The generic ingredient in OBETICHOLIC ACID is obeticholic acid. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the obeticholic acid profile page.
Summary for 214980
Tradename: | OBETICHOLIC ACID |
Applicant: | Lupin Ltd |
Ingredient: | obeticholic acid |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | May 30, 2023 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | May 30, 2023 | TE: | RLD: | No |
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