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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 085370


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NDA 085370 describes DEXTROAMPHETAMINE SULFATE, which is a drug marketed by Able, Actavis Elizabeth, Dr Reddys Labs Sa, Mylan, Nesher Pharms, Specgx Llc, Strides Pharma, Prasco, Tris Pharma Inc, Ani Pharms, Arbor Pharms Llc, Aurolife Pharma Llc, Avanthi Inc, Barr, Epic Pharma Llc, Halsey, Lannett, Mast Mm, Novel Labs Inc, Nuvo Pharm, Purepac Pharm, Sandoz, Vitarine, and Winder Labs Llc, and is included in thirty-three NDAs. It is available from fourteen suppliers. Additional details are available on the DEXTROAMPHETAMINE SULFATE profile page.

The generic ingredient in DEXTROAMPHETAMINE SULFATE is dextroamphetamine sulfate. There are eighteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the dextroamphetamine sulfate profile page.
Summary for 085370
Tradename:DEXTROAMPHETAMINE SULFATE
Applicant:Ani Pharms
Ingredient:dextroamphetamine sulfate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 085370

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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