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. It is available from one supplier. 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. Ten 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

Pharmacology for NDA: 021027

Suppliers and Packaging for NDA: 021027

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027	NDA	Genzyme Corporation	58468-0123	58468-0123-1	50 VIAL, SINGLE-USE in 1 BOX (58468-0123-1) / 2 mL in 1 VIAL, SINGLE-USE (58468-0123-0)
HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027	NDA	Genzyme Corporation	58468-0127	58468-0127-1	50 VIAL, MULTI-DOSE in 1 BOX (58468-0127-1) / 2 mL in 1 VIAL, MULTI-DOSE (58468-0127-0)

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	⤷ Sign Up	⤷ Sign Up
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	⤷ Sign Up	⤷ Sign Up
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	⤷ Sign Up	⤷ Sign Up
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-001	Apr 6, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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