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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 208614

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NDA 208614 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 208614

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	4MCG/2ML (2MCG/ML)
Approval Date:	Jul 24, 2018	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	10MCG/5ML (2MCG/ML)
Approval Date:	Jul 24, 2018	TE:		RLD:	Yes

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