Details for New Drug Application (NDA): 216720
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The generic ingredient in DEFLAZACORT is deflazacort. There are three drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the deflazacort profile page.
Summary for 216720
| Tradename: | DEFLAZACORT |
| Applicant: | Upsher Smith Labs |
| Ingredient: | deflazacort |
| Patents: | 0 |
Pharmacology for NDA: 216720
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 216720
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEFLAZACORT | deflazacort | TABLET;ORAL | 216720 | ANDA | Upsher-Smith Laboratories, LLC | 0245-0814 | 0245-0814-11 | 1 BOTTLE in 1 CARTON (0245-0814-11) / 100 TABLET in 1 BOTTLE |
| DEFLAZACORT | deflazacort | TABLET;ORAL | 216720 | ANDA | Upsher-Smith Laboratories, LLC | 0245-0815 | 0245-0815-30 | 1 BOTTLE in 1 CARTON (0245-0815-30) / 30 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 6MG | ||||
| Approval Date: | Nov 5, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 18MG | ||||
| Approval Date: | Nov 5, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Nov 5, 2024 | TE: | AB | RLD: | No | ||||
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