Orange Book product · Brand (NDA)
ZEMPLAR
PARICALCITOL
At a glance
May 26, 2005
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 26, 2005
21 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
PARICALCITOL
Strength
4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 021606
Product number
003
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.
- 2016PARICALCITOLBrand (NDA)
NDA 207174 · ACCORD HLTHCARE
- 2014PARICALCITOLBrand (NDA)
NDA 205917 · HIKMA PHARMS
- 2014PARICALCITOLBrand (NDA)
NDA 201657 · HOSPIRA
- 2000ZEMPLARBrand (NDA)
NDA 020819 · 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.
