Orange Book product · Brand (NDA)
CALCIJEX
CALCITRIOL
At a glance
Sep 25, 1986
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 25, 1986
40 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
CALCITRIOL
Strength
0.001MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 018874
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.
- 2009VECTICALBrand (NDA)
NDA 022087 · GALDERMA LABS LP
- 1998ROCALTROLBrand (NDA)
NDA 021068 · ESJAY PHARMA
- —ROCALTROLBrand (NDA)
NDA 018044 · ESJAY PHARMA
- 2026CALCITRIOLGeneric (ANDA)
ANDA 219796 · HUMANWELL PURACAP
- 2023CALCITRIOLGeneric (ANDA)
ANDA 203973 · ANDA REPOSITORY
- 2020CALCITRIOLGeneric (ANDA)
ANDA 211030 · GLAND
- 2019CALCITRIOLGeneric (ANDA)
ANDA 204556 · SUN PHARM
- 2018CALCITRIOLGeneric (ANDA)
ANDA 209798 · RISING
- 2017CALCITRIOLGeneric (ANDA)
ANDA 203289 · AMNEAL PHARMS
- 2014CALCITRIOLGeneric (ANDA)
ANDA 091356 · ONESOURCE SPECIALTY
- 2013CALCITRIOLGeneric (ANDA)
ANDA 091174 · BIONPHARMA
- 2008CALCITRIOLGeneric (ANDA)
ANDA 078066 · LONG GROVE PHARMS
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.
