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Details for New Drug Application (NDA): 208271

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NDA 208271 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: 208271

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

Pharmacology for NDA: 208271

Ingredient-typeQuaternary Ammonium Compounds
Mechanism of ActionOpioid Antagonists

Suppliers and Packaging for NDA: 208271

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RELISTOR
methylnaltrexone bromide
TABLET;ORAL 208271 NDA Salix Pharmaceuticals, Inc. 65649-150 65649-150-06 1 BOTTLE in 1 CARTON (65649-150-06) > 6 TABLET in 1 BOTTLE
RELISTOR
methylnaltrexone bromide
TABLET;ORAL 208271 NDA Salix Pharmaceuticals, Inc. 65649-150 65649-150-60 60 TABLET in 1 BOTTLE (65649-150-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jul 19, 2016TE:RLD:Yes
Patent:8,524,276Patent Expiration:Mar 10, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:8,956,651Patent Expiration:Mar 10, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:9,314,461Patent Expiration:Mar 10, 2031Product Flag?YSubstance Flag?Delist Request?


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