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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 215810

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NDA 215810 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 215810

Tradename:	DOXERCALCIFEROL
Applicant:	Alembic
Ingredient:	doxercalciferol
Patents:	0

Pharmacology for NDA: 215810

Suppliers and Packaging for NDA: 215810

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXERCALCIFEROL	doxercalciferol	INJECTABLE;INJECTION	215810	ANDA	Alembic Pharmaceuticals Inc.	62332-690	62332-690-30	50 VIAL, MULTI-DOSE in 1 CARTON (62332-690-30) / 2 mL in 1 VIAL, MULTI-DOSE (62332-690-02)
DOXERCALCIFEROL	doxercalciferol	INJECTABLE;INJECTION	215810	ANDA	Alembic Pharmaceuticals Inc.	62332-690	62332-690-50	25 VIAL, MULTI-DOSE in 1 CARTON (62332-690-50) / 2 mL in 1 VIAL, MULTI-DOSE (62332-690-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	4MCG/2ML (2MCG/ML)
Approval Date:	Jun 15, 2023	TE:	AP	RLD:	No

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