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Generated: July 20, 2017

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 Actavis Elizabeth, Lannett, Nesher Pharms, Able, Mast Mm, Purepac Pharm, Halsey, Novel Labs Inc, Mikart, Mylan Pharms Inc, Mallinckrodt, Mayne Pharma, Tris Pharma Inc, Avanthi Inc, Epic Pharma Llc, Barr, Idt Australia Ltd, Sandoz, Outlook Pharms, Vitarine, Aurolife Pharma Llc, and Vintage Pharms Llc, and is included in twenty-eight 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-five suppliers are listed for this compound. Additional details are available on the dextroamphetamine sulfate profile page.

Summary for NDA: 040367

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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)

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Teva
Healthtrust
Fish and Richardson
Accenture
QuintilesIMS
Julphar
Moodys
Johnson and Johnson
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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