DEFLAZACORT Pharmacologic Class Indexing
- Class set ID
- c0c960b1-312d-49ea-b39b-0ef5abd99b32
- Version
- 2
- Effective date
- 20180813
- Type
- Indexing - Pharmacologic Class
Mapped DailyMed Labels#
Label, Manufacturer, Effective table| Label | Manufacturer | Effective | SPL version |
|---|
| These highlights do not include all the information needed to use DEFLAZACORT ORAL SUSPENSION safely and effectively. See full prescribing information for DEFLAZACORT ORAL SUSPENSION. DEFLAZACORT oral suspension Initial U.S. Approval: 2017 Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza® (deflazacort) oral suspension. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. | Sun Pharmaceutical Industries, Inc. | Ohm Laboratories Inc. | 20260127 | 2 |
| These highlights do not include all the information needed to use DEFLAZACORT TABLETS safely and effectively. See full prescribing information for DEFLAZACORT TABLETS DEFLAZACORT tablets, for oral use Initial U.S. Approval:2017 | Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Doppel Farmaceutici S.r.l. | 20251217 | 2 |
| DEFLAZACORT tablets, for oral use These highlights do not include all the information needed to use DEFLAZACORT TABELTS safely and effectively. See full prescribing information for DEFLAZACORT TABELTS Initial U.S. Approval: 2017 | AvKARE | 20251210 | 1 |
| These highlights do not include all the information needed to use DEFLAZACORT TABLETS safely and effectively. See full prescribing information for DEFLAZACORT TABLETS. DEFLAZACORT tablets, for oral use Initial U.S. Approval: 2017 | Sun Pharmaceutical Industries, Inc. | Ohm Laboratories Inc. | 20251209 | 2 |
| These highlights do not include all the information needed to use DEFLAZACORT ORAL SUSPENSION safely and effectively. See full prescribing information for DEFLAZACORT ORAL SUSPENSION. DEFLAZACORT oral suspension Initial U.S. Approval: 2017 | Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited | 20251127 | 2 |
| These highlights do not include all the information needed to use JAYTHARI safely and effectively. See full prescribing information for JAYTHARI . JAYTHARI (deflazacort) oral suspension Initial U.S. Approval: 2017 | Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited | 20251114 | 1 |
| These highlights do not include all the information needed to use EMFLAZA ® safely and effectively. See full prescribing information for EMFLAZA. EMFLAZA ® (deflazacort) tablets, for oral use EMFLAZA ® (deflazacort) oral suspension Initial U.S. Approval: 2017 | PTC Therapeutics, Inc. | 20251113 | 21 |
| These highlights do not include all the information needed to use DEFLAZACORT ORAL SUSPENSION safely and effectively. See full prescribing information for DEFLAZACORT ORAL SUSPENSION. DEFLAZACORT oral suspension Initial U.S. Approval: 2017 | Doppel Farmaceutici S.r.l. | 20251014 | 1 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KYMBEE safely and effectively. See full prescribing information for KYMBEE. KYMBEE TM (deflazacort) tablets, for oral use Initial U.S. Approval: 2017 | Upsher-Smith Laboratories, LLC | 20250717 | 1 |
| These highlights do not include all the information needed to use PYQUVI safely and effectively. See full prescribing information for PYQUVI. PYQUVI TM (deflazacort) oral suspension Initial U.S. Approval: 2017 | Aucta Pharmaceuticals, Inc. | 20250709 | 1 |
| These highlights do not include all the information needed to use DEFLAZACORT TABLETS safely and effectively. See full prescribing information for DEFLAZACORT TABLETS . DEFLAZACORT tablets, for oral use Initial U.S. Approval: 2017 | Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private Limited | 20250616 | 3 |
| These highlights do not include all the information needed to use DEFLAZACORT ORAL SUSPENSION safely and effectively. See full prescribing information for DEFLAZACORT ORAL SUSPENSION. DEFLAZACORT oral suspension Initial U.S. Approval: 2017 Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza ® (deflazacort) oral suspension. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. | Cranbury Pharmaceuticals, LLC | 20250531 | 8 |
| These highlights do not include all the information needed to use JAYTHARI safely and effectively. See full prescribing information for JAYTHARI JAYTHARI (deflazacort) tablets, for oral use Initial U.S. Approval:2017 | Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Doppel Farmaceutici S.r.l. | 20250519 | 2 |
| These highlights do not include all the information needed to use DEFLAZACORT TABLETS safely and effectively. See full prescribing information for DEFLAZACORT TABLETS. DEFLAZACORT tablets, for oral use Initial U.S. Approval: 2017 | Upsher-Smith Laboratories, LLC | Bora Pharmaceuticals, Inc | Bora Pharmaceuticals Inc. | 20250501 | 6 |
| These highlights do not include all the information needed to use DEFLAZACORT TABLETS safely and effectively. See full prescribing information for DEFLAZACORT TABLETS. DEFLAZACORT tablets, for oral use Initial U.S. Approval: 2017 | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 20240613 | 2 |