Details for New Drug Application (NDA): 022041

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NDA 022041 describes CYANOKIT, which is a drug marketed by Btg Intl and is included in one NDA. It is available from one supplier. Additional details are available on the CYANOKIT profile page.

The generic ingredient in CYANOKIT is hydroxocobalamin. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydroxocobalamin profile page.

Summary for 022041

Tradename:	CYANOKIT
Applicant:	Btg Intl
Ingredient:	hydroxocobalamin
Patents:	0

Pharmacology for NDA: 022041

Medical Subject Heading (MeSH) Categories for 022041

Hematinics
Vitamin B Complex

Suppliers and Packaging for NDA: 022041

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CYANOKIT	hydroxocobalamin	INJECTABLE;INJECTION	022041	NDA	BTG INTERNATIONAL INC.	50633-310	50633-310-11	1 VIAL, GLASS in 1 CARTON (50633-310-11) / 250 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5GM/VIAL (5GM/KIT)
Approval Date:	Apr 8, 2011	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	2.5GM/VIAL (5GM/KIT)
Approval Date:	Dec 15, 2006	TE:		RLD:	No

Expired US Patents for NDA 022041

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Btg Intl	CYANOKIT	hydroxocobalamin	INJECTABLE;INJECTION	022041-002	Dec 15, 2006	⤷ Sign Up	⤷ Sign Up
Btg Intl	CYANOKIT	hydroxocobalamin	INJECTABLE;INJECTION	022041-001	Apr 8, 2011	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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