Details for New Drug Application (NDA): 021897

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NDA 021897 describes VIVITROL, which is a drug marketed by Alkermes and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the VIVITROL profile page.

The generic ingredient in VIVITROL is naltrexone. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the naltrexone profile page.

Summary for 021897

Tradename:	VIVITROL
Applicant:	Alkermes
Ingredient:	naltrexone
Patents:	1

Medical Subject Heading (MeSH) Categories for 021897

Narcotic Antagonists

Suppliers and Packaging for NDA: 021897

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897	NDA	Alkermes, Inc.	65757-300	65757-300-01	1 KIT in 1 CARTON (65757-300-01) * 4 mL in 1 VIAL, GLASS (65757-302-02) * 4 mL in 1 VIAL, GLASS (65757-304-03)
VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897	NDA	Alkermes, Inc.	65757-301	65757-301-01	1 KIT in 1 CARTON (65757-301-01) * 4 mL in 1 VIAL, GLASS (65757-303-02) * 4 mL in 1 VIAL, GLASS (65757-305-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR			Strength	380MG/VIAL
Approval Date:	Apr 13, 2006	TE:		RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	Oct 15, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	PREVENTION OF RELAPSE TO OPIOID DEPENDENCE, FOLLOWING OPIOID DETOXIFICATION
Patent:	⤷ Subscribe	Patent Expiration:	Oct 15, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ALCOHOL DEPENDENCE

Expired US Patents for NDA 021897

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	⤷ Subscribe	⤷ Subscribe
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	⤷ Subscribe	⤷ Subscribe
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	⤷ Subscribe	⤷ Subscribe
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	⤷ Subscribe	⤷ Subscribe
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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