Details for New Drug Application (NDA): 211759
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NDA 211759 describes VYSCOXA, which is a drug marketed by Carwin Pharm Assoc and is included in one NDA. It is available from one supplier. Additional details are available on the VYSCOXA profile page.
The generic ingredient in VYSCOXA is celecoxib. There are twenty-six drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the celecoxib profile page.
The generic ingredient in VYSCOXA is celecoxib. There are twenty-six drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the celecoxib profile page.
Summary for 211759
| Tradename: | VYSCOXA |
| Applicant: | Carwin Pharm Assoc |
| Ingredient: | celecoxib |
| Patents: | 0 |
Pharmacology for NDA: 211759
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 211759
Suppliers and Packaging for NDA: 211759
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VYSCOXA | celecoxib | SUSPENSION;ORAL | 211759 | NDA | Carwin Pharmaceutical Associates, LLC | 15370-501 | 15370-501-16 | 473 mL in 1 BOTTLE (15370-501-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 10MG/ML | ||||
| Approval Date: | Jul 29, 2025 | TE: | RLD: | Yes | |||||
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