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UBS
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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040361

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NDA 040361 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, Ani Pharms Inc, Arbor Pharms Llc, Aurolife Pharma Llc, Avanthi Inc, Barr, Epic Pharma Llc, Halsey, Lannett, Mast Mm, 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 eighteen 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 040361
Tradename:DEXTROAMPHETAMINE SULFATE
Applicant:Barr
Ingredient:dextroamphetamine sulfate
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040361
Medical Subject Heading (MeSH) Categories for 040361
Suppliers and Packaging for NDA: 040361
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET;ORAL 040361 ANDA Teva Pharmaceuticals USA, Inc. 0555-0952 N 0555-0952-02
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET;ORAL 040361 ANDA Teva Pharmaceuticals USA, Inc. 0555-0953 N 0555-0953-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jan 31, 2001TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jan 31, 2001TE:AARLD:No

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