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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 210452

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NDA 210452 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 210452

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

Pharmacology for NDA: 210452

Suppliers and Packaging for NDA: 210452

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOXERCALCIFEROL	doxercalciferol	INJECTABLE;INJECTION	210452	ANDA	Dr.Reddy's Laboratories Inc	43598-850	43598-850-50	50 VIAL, MULTI-DOSE in 1 CARTON (43598-850-50) / 2 mL in 1 VIAL, MULTI-DOSE (43598-850-11)
DOXERCALCIFEROL	doxercalciferol	INJECTABLE;INJECTION	210452	ANDA	Gland Pharma Limited	68083-300	68083-300-50	50 VIAL, SINGLE-DOSE in 1 CARTON (68083-300-50) / 2 mL in 1 VIAL, SINGLE-DOSE (68083-300-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	4MCG/2ML (2MCG/ML)
Approval Date:	Sep 26, 2019	TE:	AP	RLD:	No

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