Details for New Drug Application (NDA): 021964

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NDA 021964 describes RELISTOR, which is a drug marketed by Salix Pharms and Salix and is included in two NDAs. It is available from one supplier. There are fourteen patents protecting this drug and three Paragraph IV challenges. Additional details are available on the RELISTOR profile page.

The generic ingredient in RELISTOR is methylnaltrexone bromide. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the methylnaltrexone bromide profile page.

Summary for 021964

Tradename:	RELISTOR
Applicant:	Salix Pharms
Ingredient:	methylnaltrexone bromide
Patents:	8

Pharmacology for NDA: 021964

Mechanism of Action	Opioid Antagonists

Suppliers and Packaging for NDA: 021964

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964	NDA	Salix Pharmaceuticals, Inc.	65649-551	65649-551-02	1 VIAL, SINGLE-DOSE in 1 CARTON (65649-551-02) / .6 mL in 1 VIAL, SINGLE-DOSE
RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964	NDA	Salix Pharmaceuticals, Inc.	65649-551	65649-551-03	7 BLISTER PACK in 1 CARTON (65649-551-03) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	12MG/0.6ML (12MG/0.6ML)
Approval Date:	Apr 24, 2008	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Apr 8, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF OPIOID-INDUCED CONSTIPATION
Patent:	⤷ Sign Up	Patent Expiration:	Dec 31, 2030	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF OPIOID-INDUCED CONSTIPATION
Patent:	⤷ Sign Up	Patent Expiration:	Sep 30, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF OPIOID-INDUCED CONSTIPATION

Expired US Patents for NDA 021964

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-003	Sep 27, 2010	⤷ Sign Up	⤷ Sign Up
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-001	Apr 24, 2008	⤷ Sign Up	⤷ Sign Up
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-002	Sep 27, 2010	⤷ Sign Up	⤷ Sign Up
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-002	Sep 27, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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