APPLICATION
ANDA208112
TYPE
ANDA
ORIGINAL APPROVAL
2024-08-26
LATEST ACTION
2024-08-26
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
METHYLNALTREXONE BROMIDEDiscontinued
METHYLNALTREXONE BROMIDE 8MG/0.4ML (8MG/0.4ML) · SOLUTION · SUBCUTANEOUS
METHYLNALTREXONE BROMIDEDiscontinued
METHYLNALTREXONE BROMIDE 12MG/0.6ML (12MG/0.6ML) · SOLUTION · SUBCUTANEOUS
Approval history
2024-08-26UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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