Orange Book product · Brand (NDA)
DOXERCALCIFEROL
DOXERCALCIFEROL
At a glance
Jul 24, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 24, 2018
8 yr ago
Today
Pharmaceutical detail
Active ingredient
DOXERCALCIFEROL
Strength
10MCG/5ML (2MCG/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 208614
Product number
002
Marketing status
DISCN
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.
- 2004HECTOROLBrand (NDA)
NDA 020862 · SANOFI
- 2000HECTOROLBrand (NDA)
NDA 021027 · SANOFI
- 2023DOXERCALCIFEROLGeneric (ANDA)
ANDA 215810 · ALEMBIC
- 2022DOXERCALCIFEROLGeneric (ANDA)
ANDA 213717 · EUGIA PHARMA
- 2020DOXERCALCIFEROLGeneric (ANDA)
ANDA 205360 · AVET
- 2020DOXERCALCIFEROLGeneric (ANDA)
ANDA 211670 · MEITHEAL
- 2019DOXERCALCIFEROLGeneric (ANDA)
ANDA 203875 · SUN PHARM
- 2019DOXERCALCIFEROLGeneric (ANDA)
ANDA 210452 · GLAND
- 2018DOXERCALCIFEROLGeneric (ANDA)
ANDA 210801 · LUPIN
- 2017DOXERCALCIFEROLGeneric (ANDA)
ANDA 208974 · AMNEAL
- 2017DOXERCALCIFEROLGeneric (ANDA)
ANDA 208975 · AMNEAL
- 2016DOXERCALCIFEROLGeneric (ANDA)
ANDA 201518 · RISING
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.
