Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021964

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RELISTOR (METHYLNALTREXONE BROMIDE)
8MG/0.4ML (8MG/0.4ML)
Marketing Status: Prescription

Active Ingredient: METHYLNALTREXONE BROMIDE
Proprietary Name: RELISTOR
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 8MG/0.4ML (8MG/0.4ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021964
Product Number: 002
Approval Date: Sep 27, 2010
Applicant Holder Full Name: SALIX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RELISTOR (METHYLNALTREXONE BROMIDE)
12MG/0.6ML (12MG/0.6ML)
Marketing Status: Prescription

Active Ingredient: METHYLNALTREXONE BROMIDE
Proprietary Name: RELISTOR
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 12MG/0.6ML (12MG/0.6ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021964
Product Number: 003
Approval Date: Sep 27, 2010
Applicant Holder Full Name: SALIX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

RELISTOR (METHYLNALTREXONE BROMIDE)
12MG/0.6ML (12MG/0.6ML)
Marketing Status: Prescription

Active Ingredient: METHYLNALTREXONE BROMIDE
Proprietary Name: RELISTOR
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 12MG/0.6ML (12MG/0.6ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021964
Product Number: 001
Approval Date: Apr 24, 2008
Applicant Holder Full Name: SALIX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information