Last Updated: May 15, 2026

Details for New Drug Application (NDA): 091101

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NDA 091101 describes DOXERCALCIFEROL, which is a drug marketed by Avet, Hikma, Rising, Alembic, Amneal, Caplin, 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 091101

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	4MCG/2ML (2MCG/ML)
Approval Date:	Aug 30, 2013	TE:		RLD:	No

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