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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
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