Application Nr Approved Date Route Status External Links
ANDA075082 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Methadone Hydrochloride Tablets For Oral Suspension, Usp Contain Methadone, An Opioid Agonist Indicated For The: Detoxification Treatment Of Opioid Addiction (Heroin Or Other Morphine-Like Drugs). Maintenance Treatment Of Opioid Addiction (Heroin Or Other Morphine-Like Drugs), In Conjunction With Appropriate Social And Medical Services. Limitations Of Use Methadone Products Used For The Treatment Of Opioid Addiction In Detoxification Or Maintenance Programs Are Subject To The Conditions For Distribution And Use Required Under 42 Cfr 8.12 [See Dosage And Administration ( 2.1 )] . Methadone Hydrochloride Tablets For Oral Suspension, Usp Are An Opioid Agonist Indicated For The: Detoxification Treatment Of Opioid Addiction (Heroin Or Other Morphine-Like Drugs) ( 1 ) Maintenance Treatment Of Opioid Addiction (Heroin Or Other Morphine-Like Drugs), In Conjunction With Appropriate Social And Medical Services. ( 1 ) Limitations Of Use Methadone Products Used For The Treatment Of Opioid Addiction In Detoxification Or Maintenance Programs Are Subject To The Conditions For Distribution And Use Required Under 21 Cfr, Title 42, Sec 8. ( 1 , 2.1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Methadone Hydrochloride METHADONE HYDROCHLORIDE ZINC1530706

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