Details for New Drug Application (NDA): 217741
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The generic ingredient in DEFLAZACORT is deflazacort. There are three drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the deflazacort profile page.
Summary for 217741
| Tradename: | DEFLAZACORT |
| Applicant: | Sun Pharm |
| Ingredient: | deflazacort |
| Patents: | 0 |
Pharmacology for NDA: 217741
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 217741
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEFLAZACORT | deflazacort | TABLET;ORAL | 217741 | ANDA | Sun Pharmaceutical Industries Limited | 70095-040 | 70095-040-01 | 1 BOTTLE in 1 CARTON (70095-040-01) / 100 TABLET in 1 BOTTLE |
| DEFLAZACORT | deflazacort | TABLET;ORAL | 217741 | ANDA | Sun Pharmaceutical Industries Limited | 70095-041 | 70095-041-30 | 1 BOTTLE in 1 CARTON (70095-041-30) / 30 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 6MG | ||||
| Approval Date: | Mar 18, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 18MG | ||||
| Approval Date: | Mar 18, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Mar 18, 2025 | TE: | AB | RLD: | No | ||||
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