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
22.75MG/ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AB
Application
NDA 208685
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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 208684 · 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.
