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RELISTOR (nda021964)- (8MG/0.4ML (8MG/0.4ML),12MG/0.6ML (12MG/0.6ML),12MG/0.6ML (12MG/0.6ML))

METHYLNALTREXONE BROMIDE SALIX PHARMS
8MG/0.4ML (8MG/0.4ML),12MG/0.6ML (12MG/0.6ML),12MG/0.6ML (12MG/0.6ML)
Yes No
2030-Dec-31 2013-Apr-24
None None
None No
• RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. • RELISTOR injection is indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care.
1 5 0
Total Other Developers None
Drugs with Suitability No
8MG/0.4ML (8MG/0.4ML) ** ** - - -
12MG/0.6ML (12MG/0.6ML) ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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