Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205917

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PARICALCITOL (PARICALCITOL)
0.002MG/ML (0.002MG/ML)
Marketing Status: Prescription

Active Ingredient: PARICALCITOL
Proprietary Name: PARICALCITOL
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 0.002MG/ML (0.002MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: N205917
Product Number: 001
Approval Date: Nov 18, 2014
Applicant Holder Full Name: HIKMA PHARMACEUTICALS CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

PARICALCITOL (PARICALCITOL)
0.005MG/ML (0.005MG/ML)
Marketing Status: Prescription

Active Ingredient: PARICALCITOL
Proprietary Name: PARICALCITOL
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 0.005MG/ML (0.005MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: N205917
Product Number: 002
Approval Date: Nov 18, 2014
Applicant Holder Full Name: HIKMA PHARMACEUTICALS CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

PARICALCITOL (PARICALCITOL)
0.01MG/2ML (0.005MG/ML)
Marketing Status: Prescription

Active Ingredient: PARICALCITOL
Proprietary Name: PARICALCITOL
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 0.01MG/2ML (0.005MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: N205917
Product Number: 003
Approval Date: Nov 18, 2014
Applicant Holder Full Name: HIKMA PHARMACEUTICALS CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information