Details for New Drug Application (NDA): 214862
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NDA 214862 describes OBETICHOLIC ACID, which is a drug marketed by Apotex, Lupin Ltd, and MSN, and is included in three NDAs. Additional details are available on the OBETICHOLIC ACID profile page.
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.
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 214862
| Tradename: | OBETICHOLIC ACID |
| Applicant: | Apotex |
| 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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