Product Details for NDA 021606
ZEMPLAR (PARICALCITOL)
1MCG
Marketing Status: Prescription
2MCG
Marketing Status: Prescription
4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
1MCG
Marketing Status: Prescription
Active Ingredient: PARICALCITOL
Proprietary Name: ZEMPLAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1MCG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021606
Product Number: 001
Approval Date: May 26, 2005
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Prescription
Patent and Exclusivity Information
ZEMPLAR (PARICALCITOL)
Proprietary Name: ZEMPLAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1MCG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021606
Product Number: 001
Approval Date: May 26, 2005
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Prescription
Patent and Exclusivity Information
2MCG
Marketing Status: Prescription
Active Ingredient: PARICALCITOL
Proprietary Name: ZEMPLAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 2MCG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021606
Product Number: 002
Approval Date: May 26, 2005
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Prescription
Patent and Exclusivity Information
ZEMPLAR (PARICALCITOL)
Proprietary Name: ZEMPLAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 2MCG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021606
Product Number: 002
Approval Date: May 26, 2005
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Prescription
Patent and Exclusivity Information
4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PARICALCITOL
Proprietary Name: ZEMPLAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021606
Product Number: 003
Approval Date: May 26, 2005
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ZEMPLAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021606
Product Number: 003
Approval Date: May 26, 2005
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information