Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 201518

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DOXERCALCIFEROL (DOXERCALCIFEROL)
0.5MCG
Marketing Status: Prescription

Active Ingredient: DOXERCALCIFEROL
Proprietary Name: DOXERCALCIFEROL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.5MCG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201518
Product Number: 001
Approval Date: Sep 9, 2016
Applicant Holder Full Name: RISING PHARMA HOLDINGS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DOXERCALCIFEROL (DOXERCALCIFEROL)
1MCG
Marketing Status: Prescription

Active Ingredient: DOXERCALCIFEROL
Proprietary Name: DOXERCALCIFEROL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1MCG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201518
Product Number: 002
Approval Date: Sep 9, 2016
Applicant Holder Full Name: RISING PHARMA HOLDINGS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DOXERCALCIFEROL (DOXERCALCIFEROL)
2.5MCG
Marketing Status: Prescription

Active Ingredient: DOXERCALCIFEROL
Proprietary Name: DOXERCALCIFEROL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 2.5MCG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201518
Product Number: 003
Approval Date: Sep 9, 2016
Applicant Holder Full Name: RISING PHARMA HOLDINGS INC
Marketing Status:  Prescription
Patent and Exclusivity Information