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Details for New Drug Application (NDA): 083903

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NDA 083903 describes DEXTROAMPHETAMINE SULFATE, which is a drug marketed by Actavis Elizabeth, Lannett, Able, Mast Mm, Purepac Pharm, Halsey, Novel Labs Inc, Mikart, Mylan Pharms Inc, Mallinckrodt, Mayne Pharma, Tris Pharma Inc, Avanthi Inc, Corepharma, Barr, Nesher Pharms, Idt Australia Ltd, Sandoz, Outlook Pharms, Vitarine, Aurolife Pharma Llc, and Vintage Pharms Llc, and is included in twenty-seven NDAs. It is available from twenty-four suppliers. Additional details are available on the DEXTROAMPHETAMINE SULFATE profile page.

The generic ingredient in DEXTROAMPHETAMINE SULFATE is dextroamphetamine sulfate. There are sixteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the dextroamphetamine sulfate profile page.

Summary for NDA: 083903

Tradename:
DEXTROAMPHETAMINE SULFATE
Applicant:
Lannett
Ingredient:
dextroamphetamine sulfate
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Summary for product number 001

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

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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