← FDA Drug Approvals (Drugs@FDA)
METHYLNALTREXONE BROMIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN LABS LTD · Approved 2025-05-28
Drug application
- FDA Application #
ANDA208592
- 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
- Discontinued
- Sponsor
- MYLAN LABS LTD
- First approval
- 2025-05-28
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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