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 two suppliers. Additional details are available on the CHOLBAM profile page.
The generic ingredient in CHOLBAM is cholic acid. There are forty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cholic acid profile page.
The generic ingredient in CHOLBAM is cholic acid. There are forty-four drug master file entries for this compound. Two suppliers are 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 | Manchester Pharmaceuticals, LLC | 45043-001 | 45043-001-02 | 90 CAPSULE in 1 BOTTLE (45043-001-02) |
| CHOLBAM | cholic acid | CAPSULE;ORAL | 205750 | NDA | Manchester Pharmaceuticals, LLC | 45043-002 | 45043-002-02 | 90 CAPSULE in 1 BOTTLE (45043-002-02) |
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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