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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018044

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ROCALTROL (CALCITRIOL)
0.25MCG
Marketing Status: Prescription
Active Ingredient: CALCITRIOL
Proprietary Name: ROCALTROL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.25MCG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018044
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
ROCALTROL (CALCITRIOL)
0.5MCG
Marketing Status: Prescription
Active Ingredient: CALCITRIOL
Proprietary Name: ROCALTROL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.5MCG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018044
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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