Active ingredient
Deflazacort
54 finished FDA listings contain Deflazacort as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DEFLAZACORT
- Dosage forms
- Suspension, Tablet
- Routes
- Oral
- Manufacturers / labelers
- 11
- Strengths listed
- 18 mg/1 · 22.75 mg/ml · 30 mg/1 · 36 mg/1 · 6 mg/1
- Brand names in FDA listings
- Deflazacort Oral Suspension, Emflaza, Jaythari, Jaythari Oral Suspension, Kymbee, Pyquvi
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 22396
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 208684 | PTC THERAP | 2017-02-09 | 4 |
| NDA 208685 | PTC THERAP | 2017-02-09 | 1 |
| ANDA 217123 | AUROBINDO PHARMA LTD | 2024-02-09 | 4 |
| ANDA 217813 | TRIS PHARMA INC | 2024-04-25 | 1 |
| ANDA 216720 | UPSHER SMITH LABS | 2024-11-05 | 8 |
| ANDA 217741 | SUN PHARM | 2025-03-18 | 4 |
| ANDA 219254 | ZYDUS LIFESCIENCES | 2025-04-08 | 20 |
| ANDA 219417 | AUCTA | 2025-06-30 | 1 |
| ANDA 216992 | UPSHER SMITH LABS | 2025-08-11 | 1 |
| ANDA 220042 | ZYDUS LIFESCIENCES | 2025-10-03 | 4 |
| ANDA 217173 | AMNEAL | 2025-12-12 | 4 |
| ANDA 219930 | SUN PHARM INDS INC | 2026-01-27 | 1 |
| ANDA 220709 | BIOCON PHARMA | 2026-05-28 | 1 |
Official labeling on DailyMed
- JAYTHARI ORAL SUSPENSION (DEFLAZACORT) SUSPENSION [DOPPEL FARMACEUTICI S.R.L.] · version 2 · 2026-09-11
- JAYTHARI (DEFLAZACORT) TABLET [DOPPEL FARMACEUTICI S.R.L.] · version 3 · 2026-08-31
- DEFLAZACORT TABLET [DOPPEL FARMACEUTICI S.R.L.] · version 4 · 2026-08-31
- DEFLAZACORT ORAL SUSPENSION (DEFLAZACORT ORAL) SUSPENSION [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 3 · 2026-08-27
- DEFLAZACORT ORAL SUSPENSION (DEFLAZACORT) SUSPENSION [DOPPEL FARMACEUTICI S.R.L.] · version 2 · 2026-08-03
- JAYTHARI (DEFLAZACORT) TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] · version 3 · 2026-07-28
- DEFLAZACORT TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] · version 3 · 2026-07-28
- DEFLAZACORT TABLET [UPSHER-SMITH LABORATORIES, LLC] · version 7 · 2026-07-07
- KYMBEE (DEFLAZACORT) SUSPENSION [UPSHER-SMITH LABORATORIES, LLC] · version 3 · 2026-06-22
- DEFLAZACORT TABLET [AUROBINDO PHARMA LIMITED] · version 3 · 2026-06-11
- DEFLAZACORT ORAL SUSPENSION (DEFLAZACORT ORAL) SUSPENSION [CRANBURY PHARMACEUTICALS, LLC] · version 9 · 2026-06-11
- DEFLAZACORT TABLET DEFLAZACORT TABLET [AMNEAL PHARMACEUTICALS NY LLC] · version 3 · 2025-12-17
Showing the 12 most recent of 17 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.