🇺🇸 FDA

Drug profile · INN

naltrexone

MYSIMBA

approved A08AA
US status
approved
Patents linked
0
News articles
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Quick answer

naltrexone (MYSIMBA) is an FDA-listed pharmaceutical active ingredient. Associated with Teva Pharma GmbH. Route of administration: intramuscular. Current US regulatory status: approved.

Key facts

INN naltrexone
Brand MYSIMBA
Route INTRAMUSCULAR
Formulation FOR SUSPENSION, EXTENDED RELEASE
ATC code A08AA

Frequently asked questions

What is naltrexone?

naltrexone (MYSIMBA) is an FDA-listed pharmaceutical active ingredient. Associated with Teva Pharma GmbH. Route of administration: intramuscular. Current US regulatory status: approved.

What is the brand name for naltrexone?

MYSIMBA is a marketed brand name for naltrexone. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of naltrexone?

naltrexone has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.