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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 021027

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NDA 021027 describes HECTOROL, which is a drug marketed by Sanofi and is included in two NDAs. Additional details are available on the HECTOROL profile page.

The generic ingredient in HECTOROL is doxercalciferol. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the doxercalciferol profile page.

Summary for 021027

Tradename:	HECTOROL
Applicant:	Sanofi
Ingredient:	doxercalciferol
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	4MCG/2ML (2MCG/ML)
Approval Date:	Apr 6, 2000	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	2MCG/ML (2MCG/ML)
Approval Date:	Apr 6, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 021027

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-002	Apr 6, 2000	5,602,116	⤷ Start Trial
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	7,148,211	⤷ Start Trial
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-002	Apr 6, 2000	7,148,211	⤷ Start Trial
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	6,903,083	⤷ Start Trial
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	5,707,980	⤷ Start Trial
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	5,602,116	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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