Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020862

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HECTOROL (DOXERCALCIFEROL)
0.5MCG Marketing Status: Prescription

Active Ingredient: DOXERCALCIFEROL
Proprietary Name: HECTOROL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.5MCG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020862
Product Number: 002
Approval Date: Apr 23, 2004
Applicant Holder Full Name: GENZYME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

HECTOROL (DOXERCALCIFEROL)
1MCG Marketing Status: Prescription

Active Ingredient: DOXERCALCIFEROL
Proprietary Name: HECTOROL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1MCG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020862
Product Number: 003
Approval Date: Jul 13, 2009
Applicant Holder Full Name: GENZYME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

HECTOROL (DOXERCALCIFEROL)
2.5MCG Marketing Status: Prescription

Active Ingredient: DOXERCALCIFEROL
Proprietary Name: HECTOROL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 2.5MCG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020862
Product Number: 001
Approval Date: Jun 9, 1999
Applicant Holder Full Name: GENZYME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

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