Orange Book product · Brand (NDA)
HECTOROL
DOXERCALCIFEROL
At a glance
Jun 09, 1999
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 09, 1999
27 yr 5 mo ago
Today
Exclusivity ends · M-14
New use / labeling-change exclusivity (3 years)
Jun 11, 2028
in 2 yr
Pharmaceutical detail
Active ingredient
DOXERCALCIFEROL
Strength
2.5MCG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 020862
Product number
001
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.
- 2018DOXERCALCIFEROLBrand (NDA)
NDA 208614 · HOSPIRA
- 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
Marketing exclusivity (1)
- M-14New use / labeling-change exclusivity (3 years)
Jun 11, 2028
in 2 yr
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.
