Orange Book product · Brand (NDA)
ZEMPLAR
PARICALCITOL
At a glance
Feb 01, 2000
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 01, 2000
26 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
PARICALCITOL
Strength
0.002MG/ML (0.002MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 020819
Product number
002
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.
- 2016PARICALCITOLBrand (NDA)
NDA 207174 · ACCORD HLTHCARE
- 2014PARICALCITOLBrand (NDA)
NDA 205917 · HIKMA PHARMS
- 2014PARICALCITOLBrand (NDA)
NDA 201657 · HOSPIRA
- 2005ZEMPLARBrand (NDA)
NDA 021606 · ABBVIE
- 2018PARICALCITOLGeneric (ANDA)
ANDA 205982 · EUGIA PHARMA
- 2017PARICALCITOLGeneric (ANDA)
ANDA 203897 · RISING
- 2017PARICALCITOLGeneric (ANDA)
ANDA 207692 · EPIC PHARMA LLC
- 2017PARICALCITOLGeneric (ANDA)
ANDA 206699 · AMNEAL PHARMS CO
- 2016PARICALCITOLGeneric (ANDA)
ANDA 204948 · MARKSANS PHARMA
- 2016PARICALCITOLGeneric (ANDA)
ANDA 204910 · CAPLIN
- 2016PARICALCITOLGeneric (ANDA)
ANDA 206710 · LOTUS PHARM CO LTD
- 2016PARICALCITOLGeneric (ANDA)
ANDA 207672 · AUROBINDO PHARMA LTD
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.
