FDA
Methylnaltrexone Bromide
The FDA lists this product in 4 strengths and forms.
Composition
- Active ingredients
- METHYLNALTREXONE BROMIDE 8MG/0.4ML (8MG/0.4ML)
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- METHYLNALTREXONE BROMIDE 12MG/0.6ML · SolutionANDA208038-001 · Tentative approval
- METHYLNALTREXONE BROMIDE 8MG/0.4ML (8MG/0.4ML) · SolutionThis page
- METHYLNALTREXONE BROMIDE 12MG/0.6ML (12MG/0.6ML) · SolutionANDA208112-002 · Discontinued
- METHYLNALTREXONE BROMIDE 12MG/0.6ML (12MG/0.6ML) · SolutionANDA208592-001 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA208112.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Methylnaltrexone Bromide
- Route
- Subcutaneous
- Dosage form
- Solution
- Applicant
- Actavis LLC
- Status
- Discontinued
- FDA approval
- 26 Aug 2024
- Application
- ANDA208112-001