Details for New Drug Application (NDA): 020862

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NDA 020862 describes HECTOROL, which is a drug marketed by Sanofi and is included in two NDAs. It is available from two suppliers. 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. Twelve suppliers are listed for this compound. Additional details are available on the doxercalciferol profile page.

Summary for 020862

Tradename:	HECTOROL
Applicant:	Sanofi
Ingredient:	doxercalciferol
Patents:	0
Formulation / Manufacturing:	see details

Suppliers and Packaging for NDA: 020862

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HECTOROL	doxercalciferol	CAPSULE;ORAL	020862	NDA AUTHORIZED GENERIC	Winthrop U.S, a business of sanofi-aventis U.S. LLC	0955-1720	0955-1720-50	1 BOTTLE in 1 CARTON (0955-1720-50) / 50 CAPSULE in 1 BOTTLE
HECTOROL	doxercalciferol	CAPSULE;ORAL	020862	NDA AUTHORIZED GENERIC	Winthrop U.S, a business of sanofi-aventis U.S. LLC	0955-1721	0955-1721-50	1 BOTTLE in 1 CARTON (0955-1721-50) / 50 CAPSULE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	2.5MCG
Approval Date:	Jun 9, 1999	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.5MCG
Approval Date:	Apr 23, 2004	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	1MCG
Approval Date:	Jul 13, 2009	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020862

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	See Plans and Pricing	See Plans and Pricing
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-002	Apr 23, 2004	See Plans and Pricing	See Plans and Pricing
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	See Plans and Pricing	See Plans and Pricing
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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