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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 201518

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NDA 201518 describes DOXERCALCIFEROL, which is a drug marketed by Avet, Hikma, Rising, Alembic, Amneal, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, 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. Nine suppliers are listed for this compound. Additional details are available on the doxercalciferol profile page.

Summary for 201518

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.5MCG
Approval Date:	Sep 9, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	1MCG
Approval Date:	Sep 9, 2016	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	2.5MCG
Approval Date:	Sep 9, 2016	TE:	AB	RLD:	No

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