Details for New Drug Application (NDA): 219417
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NDA 219417 describes PYQUVI, which is a drug marketed by Aucta and is included in one NDA. It is available from one supplier. Additional details are available on the PYQUVI profile page.
The generic ingredient in PYQUVI is deflazacort. There is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the deflazacort profile page.
The generic ingredient in PYQUVI is deflazacort. There is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the deflazacort profile page.
Summary for 219417
| Tradename: | PYQUVI |
| Applicant: | Aucta |
| Ingredient: | deflazacort |
| Patents: | 0 |
Pharmacology for NDA: 219417
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 219417
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PYQUVI | deflazacort | SUSPENSION;ORAL | 219417 | ANDA | Aucta Pharmaceuticals, Inc. | 73289-0089 | 73289-0089-1 | 13 mL in 1 BOTTLE (73289-0089-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 22.75MG/ML | ||||
| Approval Date: | Jun 30, 2025 | TE: | AB | RLD: | No | ||||
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