FDA
Methylnaltrexone Bromide
The FDA lists this product in 4 strengths and forms.
Composition
- Active ingredients
- METHYLNALTREXONE BROMIDE 12MG/0.6ML
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- METHYLNALTREXONE BROMIDE 12MG/0.6ML · SolutionThis page
- METHYLNALTREXONE BROMIDE 8MG/0.4ML (8MG/0.4ML) · SolutionANDA208112-001 · Discontinued
- 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 ANDA208038.
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
- US Generics, Steriles
- Status
- Tentative approval
- FDA approval
- 12 Aug 2021
- Application
- ANDA208038-001