Orange Book product · Brand (NDA)
EMFLAZA
DEFLAZACORT
At a glance
Feb 09, 2017
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 09, 2017
9 yr 6 mo ago
Exclusivity ends · ODE-252
Orphan-drug exclusivity (7 years)
Jun 07, 2026
12 d ago
Today
Pharmaceutical detail
Active ingredient
DEFLAZACORT
Strength
6MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 208684
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2017EMFLAZABrand (NDA)
NDA 208685 · PTC THERAP
- 2026DEFLAZACORTGeneric (ANDA)
ANDA 220709 · CARNEGIE
- 2026DEFLAZACORTGeneric (ANDA)
ANDA 219930 · SUN PHARM INDS INC
- 2025DEFLAZACORTGeneric (ANDA)
ANDA 217173 · AMNEAL
- 2025DEFLAZACORTGeneric (ANDA)
ANDA 220042 · ZYDUS LIFESCIENCES
- 2025DEFLAZACORTGeneric (ANDA)
ANDA 216992 · UPSHER SMITH LABS
- 2025PYQUVIGeneric (ANDA)
ANDA 219417 · AUCTA
- 2025JAYTHARIGeneric (ANDA)
ANDA 219254 · ZYDUS LIFESCIENCES
- 2025DEFLAZACORTGeneric (ANDA)
ANDA 217741 · SUN PHARM
- 2024DEFLAZACORTGeneric (ANDA)
ANDA 216720 · UPSHER SMITH LABS
- 2024DEFLAZACORTGeneric (ANDA)
ANDA 217813 · TRIS PHARMA INC
- 2024DEFLAZACORTGeneric (ANDA)
ANDA 217123 · AUROBINDO PHARMA LTD
Marketing exclusivity (1)
- ODE-252Orphan-drug exclusivity (7 years)
Jun 07, 2026
12 d ago
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
