Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021606

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ZEMPLAR (PARICALCITOL)
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)
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)
4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued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Strength: 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

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