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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 Pharms Inc and is included in two NDAs. It is available from one supplier. There are nine 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 two 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 NDA: 021964

Tradename:
RELISTOR
Applicant:
Salix Pharms
Ingredient:
methylnaltrexone bromide
Patents:6

Pharmacology for NDA: 021964

Ingredient-typeQuaternary Ammonium Compounds
Mechanism of ActionOpioid 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength12MG/0.6ML (12MG/0.6ML)
Approval Date:Apr 24, 2008TE:RLD:Yes
Patent:8,552,025Patent Expiration:Apr 8, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:6,559,158Patent Expiration:Nov 3, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF OPIOID-INDUCED CONSTIPATION
Patent:8,247,425Patent Expiration:Dec 31, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF OPIOID-INDUCED CONSTIPATION


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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