Details for New Drug Application (NDA): 219930
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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 219930
| Tradename: | DEFLAZACORT |
| Applicant: | Sun Pharm Inds Inc |
| Ingredient: | deflazacort |
| Patents: | 0 |
Pharmacology for NDA: 219930
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 219930
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEFLAZACORT | deflazacort | SUSPENSION;ORAL | 219930 | ANDA | Sun Pharmaceutical Industries, Inc. | 57664-993 | 57664-993-01 | 13 mL in 1 BOTTLE (57664-993-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 22.75MG/ML | ||||
| Approval Date: | Jan 27, 2026 | TE: | AB | RLD: | No | ||||
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