Details for New Drug Application (NDA): 217927
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NDA 217927 describes COXANTO, which is a drug marketed by Solubiomix and is included in one NDA. It is available from three suppliers. Additional details are available on the COXANTO profile page.
The generic ingredient in COXANTO is oxaprozin. There are thirteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the oxaprozin profile page.
The generic ingredient in COXANTO is oxaprozin. There are thirteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the oxaprozin profile page.
Summary for 217927
| Tradename: | COXANTO |
| Applicant: | Solubiomix |
| Ingredient: | oxaprozin |
| Patents: | 0 |
Pharmacology for NDA: 217927
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 217927
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COXANTO | oxaprozin | CAPSULE;ORAL | 217927 | NDA | Solubiomix, LLC | 69499-403 | 69499-403-60 | 60 CAPSULE in 1 BOTTLE (69499-403-60) |
| COXANTO | oxaprozin | CAPSULE;ORAL | 217927 | NDA | SOLA Pharmaceuticals, LLC | 70512-787 | 70512-787-60 | 60 CAPSULE in 1 BOTTLE (70512-787-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
| Approval Date: | Oct 20, 2023 | TE: | RLD: | Yes | |||||
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