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Last Updated: December 11, 2025

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. Eight 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:	RX	Dosage:	INJECTABLE;INJECTION			Strength	4MCG/2ML (2MCG/ML)
Approval Date:	Apr 6, 2000	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2MCG/ML (2MCG/ML)
Approval Date:	Apr 6, 2000	TE:	AP	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	⤷ Get Started Free	⤷ Get Started Free
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	⤷ Get Started Free	⤷ Get Started Free
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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