Orange Book product · Brand (NDA)
ROCALTROL
CALCITRIOL
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
CALCITRIOL
Strength
0.25MCG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 018044
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.
- 2009VECTICALBrand (NDA)
NDA 022087 · GALDERMA LABS LP
- 1998ROCALTROLBrand (NDA)
NDA 021068 · ESJAY PHARMA
- 1986CALCIJEXBrand (NDA)
NDA 018874 · ABBVIE
- 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.
