Details for New Drug Application (NDA): 205750
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NDA 205750 describes CHOLBAM, 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 CHOLBAM profile page.
The generic ingredient in CHOLBAM is cholic acid. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the cholic acid profile page.
The generic ingredient in CHOLBAM is cholic acid. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the cholic acid profile page.
Summary for 205750
| Tradename: | CHOLBAM |
| Applicant: | Mirum |
| Ingredient: | cholic acid |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205750
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHOLBAM | cholic acid | CAPSULE;ORAL | 205750 | NDA | Mirum Pharmaceuticals Inc. | 79378-001 | 79378-001-02 | 90 CAPSULE in 1 BOTTLE (79378-001-02) |
| CHOLBAM | cholic acid | CAPSULE;ORAL | 205750 | NDA | Mirum Pharmaceuticals Inc. | 79378-002 | 79378-002-02 | 90 CAPSULE in 1 BOTTLE (79378-002-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Mar 17, 2015 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
| Approval Date: | Mar 17, 2015 | TE: | RLD: | Yes | |||||
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