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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 208974

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DOXERCALCIFEROL (DOXERCALCIFEROL)
2MCG/ML (2MCG/ML)
Marketing Status: Discontinued
Active Ingredient: DOXERCALCIFEROL
Proprietary Name: DOXERCALCIFEROL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2MCG/ML (2MCG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A208974
Product Number: 001
Approval Date: May 24, 2017
Applicant Holder Full Name: AMNEAL EU LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
DOXERCALCIFEROL (DOXERCALCIFEROL)
4MCG/2ML (2MCG/ML)
Marketing Status: Discontinued
Active Ingredient: DOXERCALCIFEROL
Proprietary Name: DOXERCALCIFEROL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 4MCG/2ML (2MCG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A208974
Product Number: 002
Approval Date: May 24, 2017
Applicant Holder Full Name: AMNEAL EU LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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