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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 208974


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NDA 208974 describes DOXERCALCIFEROL, which is a drug marketed by Avet, Hikma, Rising, Alembic, Amneal, Epic Pharma Llc, Eugia Pharma, Gland, Hospira, Lupin Ltd, Meitheal, Sandoz, and Sun Pharm, and is included in sixteen NDAs. It is available from eight suppliers. Additional details are available on the DOXERCALCIFEROL profile page.

The generic ingredient in DOXERCALCIFEROL is doxercalciferol. There are nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the doxercalciferol profile page.
Summary for 208974
Tradename:DOXERCALCIFEROL
Applicant:Amneal
Ingredient:doxercalciferol
Patents:0
Pharmacology for NDA: 208974
Suppliers and Packaging for NDA: 208974
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 208974 ANDA Amneal Pharmaceuticals LLC 70121-1392 70121-1392-5 50 VIAL, SINGLE-DOSE in 1 CARTON (70121-1392-5) / 2 mL in 1 VIAL, SINGLE-DOSE (70121-1392-1)
DOXERCALCIFEROL doxercalciferol INJECTABLE;INJECTION 208974 ANDA Amneal Pharmaceuticals LLC 70121-1392 70121-1392-6 25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1392-6) / 2 mL in 1 VIAL, SINGLE-DOSE (70121-1392-1)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength2MCG/ML (2MCG/ML)
Approval Date:May 24, 2017TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength4MCG/2ML (2MCG/ML)
Approval Date:May 24, 2017TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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