← FDA Drug Approvals (Drugs@FDA)
METHYLNALTREXONE BROMIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: US GENERICS, STERILES · Approved 2021-08-12
Drug application
- FDA Application #
ANDA208038- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- METHYLNALTREXONE BROMIDE
- Generic name
- Methylnaltrexone Bromide
- Active ingredients
- METHYLNALTREXONE BROMIDE
- Dosage form
- SOLUTION
- Route
- SUBCUTANEOUS
- Marketing status
- None (Tentative Approval)
- Sponsor
- US GENERICS, STERILES
- First approval
- 2021-08-12
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown