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Generated: April 21, 2019

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Details for New Drug Application (NDA): 040050

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NDA 040050 describes METHADOSE, which is a drug marketed by Specgx Llc and is included in three NDAs. It is available from three suppliers. Additional details are available on the METHADOSE profile page.

The generic ingredient in METHADOSE is methadone hydrochloride. There are thirteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.
Summary for 040050
Tradename:METHADOSE
Applicant:Specgx Llc
Ingredient:methadone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 040050

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 15, 1993TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 15, 1993TE:AARLD:No

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