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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Express Scripts
Covington
Accenture
Farmers Insurance
Queensland Health
Chubb
Harvard Business School
Chinese Patent Office
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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203548

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NDA 203548 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 203548
Tradename:DEXTROAMPHETAMINE SULFATE
Applicant:Avanthi Inc
Ingredient:dextroamphetamine sulfate
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203548
Medical Subject Heading (MeSH) Categories for 203548
Suppliers and Packaging for NDA: 203548
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET;ORAL 203548 ANDA KVK-Tech, Inc. 10702-065 10702-065-03 30 TABLET in 1 BOTTLE (10702-065-03)
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET;ORAL 203548 ANDA KVK-Tech, Inc. 10702-065 10702-065-06 60 TABLET in 1 BOTTLE (10702-065-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 23, 2015TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 23, 2015TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Queensland Health
Fuji
Chinese Patent Office
Federal Trade Commission
Argus Health
Baxter
Dow

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