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Serving leading biopharmaceutical companies globally:

Colorcon
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US Department of Justice
Harvard Business School
Julphar
Healthtrust
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UBS
Fish and Richardson

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040365

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NDA 040365 describes DEXTROAMPHETAMINE SULFATE, which is a drug marketed by Able, Actavis Elizabeth, Mallinckrodt, Mayne Pharma, Mylan Pharms Inc, Nesher Pharms, Vintage Pharms, Outlook Pharms, Tris Pharma Inc, Aurolife Pharma Llc, Avanthi Inc, Barr, Epic Pharma Llc, Halsey, Idt Australia Ltd, Lannett, Mast Mm, Mikart, Novel Labs Inc, Purepac Pharm, Sandoz, Sunrise Pharm Inc, Vintage Pharms Llc, and Vitarine, and is included in thirty NDAs. It is available from twenty-three suppliers. Additional details are available on the DEXTROAMPHETAMINE SULFATE profile page.

The generic ingredient in DEXTROAMPHETAMINE SULFATE is dextroamphetamine sulfate. There are seventeen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the dextroamphetamine sulfate profile page.
Summary for 040365
Tradename:DEXTROAMPHETAMINE SULFATE
Applicant:Nesher Pharms
Ingredient:dextroamphetamine sulfate
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040365
Medical Subject Heading (MeSH) Categories for 040365
Suppliers and Packaging for NDA: 040365
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET;ORAL 040365 ANDA Ethex Corporation 58177-311 58177-311-04 100 TABLET in 1 BOTTLE (58177-311-04)
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET;ORAL 040365 ANDA Ethex Corporation 58177-311 58177-311-09 1000 TABLET in 1 BOTTLE (58177-311-09)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Oct 31, 2002TE:RLD:No

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Serving leading biopharmaceutical companies globally:

McKinsey
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Argus Health
Daiichi Sankyo
US Department of Justice
Merck
Express Scripts
Covington
QuintilesIMS

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