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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021068

ROCALTROL (CALCITRIOL)
1MCG/ML
Marketing Status: Prescription
Active Ingredient: CALCITRIOL
Proprietary Name: ROCALTROL
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 1MCG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AA
Application Number: N021068
Product Number: 001
Approval Date: Nov 20, 1998
Applicant Holder Full Name: SS PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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