Orange Book product · Brand (NDA)
ROCALTROL
CALCITRIOL
At a glance
Nov 20, 1998
Approved
Brand (NDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 20, 1998
28 yr ago
Today
Pharmaceutical detail
Active ingredient
CALCITRIOL
Strength
1MCG/ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
NDA 021068
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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
- 1986CALCIJEXBrand (NDA)
NDA 018874 · ABBVIE
- —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.
