Details for New Drug Application (NDA): 217813
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NDA 217813 describes DEFLAZACORT, which is a drug marketed by Tris Pharma Inc, Aurobindo Pharma Ltd, and Upsher Smith Labs, and is included in three NDAs. It is available from two suppliers. Additional details are available on the DEFLAZACORT profile page.
The generic ingredient in DEFLAZACORT is deflazacort. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the deflazacort profile page.
The generic ingredient in DEFLAZACORT is deflazacort. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the deflazacort profile page.
Summary for 217813
| Tradename: | DEFLAZACORT |
| Applicant: | Tris Pharma Inc |
| Ingredient: | deflazacort |
| Patents: | 0 |
Pharmacology for NDA: 217813
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 217813
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEFLAZACORT | deflazacort | SUSPENSION;ORAL | 217813 | ANDA | Tris Pharma Inc | 27808-249 | 27808-249-01 | 13 mL in 1 BOTTLE (27808-249-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 22.75MG/ML | ||||
| Approval Date: | Apr 25, 2024 | TE: | AB | RLD: | No | ||||
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