Orange Book product · Brand (NDA)
AFINITOR DISPERZ
EVEROLIMUS
At a glance
Aug 29, 2012
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 29, 2012
14 yr ago
Today
Pharmaceutical detail
Active ingredient
EVEROLIMUS
Strength
2MG
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
TE code
AB
Application
NDA 203985
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.
- 2010AFINITORBrand (NDA)
NDA 022334 · NOVARTIS
- 2010ZORTRESSBrand (NDA)
NDA 021560 · NOVARTIS
- 2026EVEROLIMUSGeneric (ANDA)
ANDA 218488 · APOTEX
- 2026EVEROLIMUSGeneric (ANDA)
ANDA 219533 · EUGIA PHARMA
- 2026EVEROLIMUSGeneric (ANDA)
ANDA 217216 · BIOCON PHARMA
- 2025EVEROLIMUSGeneric (ANDA)
ANDA 219955 · NOVUGEN
- 2025EVEROLIMUSGeneric (ANDA)
ANDA 216140 · BIOCON PHARMA
- 2025EVEROLIMUSGeneric (ANDA)
ANDA 217640 · NATCO
- 2025EVEROLIMUSGeneric (ANDA)
ANDA 218863 · AMNEAL
- 2021EVEROLIMUSGeneric (ANDA)
ANDA 214138 · ALKEM LABS LTD
- 2021EVEROLIMUSGeneric (ANDA)
ANDA 205775 · PH HEALTH
- 2021EVEROLIMUSGeneric (ANDA)
ANDA 205432 · BRECKENRIDGE
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.
