Details for New Drug Application (NDA): 217123
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NDA 217123 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 217123
| Tradename: | DEFLAZACORT |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | deflazacort |
| Patents: | 0 |
Pharmacology for NDA: 217123
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 217123
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEFLAZACORT | deflazacort | TABLET;ORAL | 217123 | ANDA | Aurobindo Pharma Limited | 59651-599 | 59651-599-01 | 100 TABLET in 1 BOTTLE (59651-599-01) |
| DEFLAZACORT | deflazacort | TABLET;ORAL | 217123 | ANDA | Aurobindo Pharma Limited | 59651-600 | 59651-600-30 | 30 TABLET in 1 BOTTLE (59651-600-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 6MG | ||||
| Approval Date: | Feb 9, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 18MG | ||||
| Approval Date: | Feb 9, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Feb 9, 2024 | TE: | AB | RLD: | No | ||||
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