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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Harvard Business School
Federal Trade Commission
Julphar
McKesson
AstraZeneca
QuintilesIMS
Dow
Cipla

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203644

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NDA 203644 describes DEXTROAMPHETAMINE SULFATE, which is a drug marketed by Able, Actavis Elizabeth, Mayne Pharma, Mylan Pharms Inc, Nesher Pharms, Specgx Llc, 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-two 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. Twenty-five suppliers are listed for this compound. Additional details are available on the dextroamphetamine sulfate profile page.
Summary for 203644
Tradename:DEXTROAMPHETAMINE SULFATE
Applicant:Tris Pharma Inc
Ingredient:dextroamphetamine sulfate
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203644
Medical Subject Heading (MeSH) Categories for 203644
Suppliers and Packaging for NDA: 203644
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate SOLUTION;ORAL 203644 ANDA Tris Pharma Inc 27808-085 N 27808-085-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/5ML
Approval Date:May 29, 2013TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Colorcon
Chinese Patent Office
Healthtrust
US Army
Argus Health
Fish and Richardson
Accenture
Cipla

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