Details for New Drug Application (NDA): 219488
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NDA 219488 describes CTEXLI, which is a drug marketed by Mirum and is included in one NDA. It is available from one supplier. Additional details are available on the CTEXLI profile page.
The generic ingredient in CTEXLI is chenodiol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the chenodiol profile page.
The generic ingredient in CTEXLI is chenodiol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the chenodiol profile page.
Suppliers and Packaging for NDA: 219488
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CTEXLI | chenodiol | TABLET;ORAL | 219488 | NDA | Mirum Pharmaceuticals Inc. | 79378-310 | 79378-310-90 | 100 TABLET, FILM COATED in 1 BOTTLE (79378-310-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Feb 21, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 21, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
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