BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Baxter
UBS
McKesson
AstraZeneca
Boehringer Ingelheim
Fuji
McKinsey
Moodys
Healthtrust

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040367

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NDA 040367 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 040367
Tradename:DEXTROAMPHETAMINE SULFATE
Applicant:Nesher Pharms
Ingredient:dextroamphetamine sulfate
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040367
Medical Subject Heading (MeSH) Categories for 040367
Suppliers and Packaging for NDA: 040367
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET;ORAL 040367 ANDA Ethex Corporation 58177-312 58177-312-04 100 TABLET in 1 BOTTLE (58177-312-04)
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET;ORAL 040367 ANDA Ethex Corporation 58177-312 58177-312-09 1000 TABLET in 1 BOTTLE (58177-312-09)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Oct 31, 2002TE:RLD:No

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Medtronic
QuintilesIMS
Julphar
Chubb
Healthtrust
US Department of Justice
Chinese Patent Office
Dow

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