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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090652

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NDA 090652 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 090652
Tradename:DEXTROAMPHETAMINE SULFATE
Applicant:Epic Pharma Llc
Ingredient:dextroamphetamine sulfate
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090652
Medical Subject Heading (MeSH) Categories for 090652
Suppliers and Packaging for NDA: 090652
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET;ORAL 090652 ANDA Avera McKennan Hospital 69189-0548 N 69189-0548-1

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Mar 7, 2014TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Mar 7, 2014TE:RLD:No

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