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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206588

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NDA 206588 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 206588
Tradename:DEXTROAMPHETAMINE SULFATE
Applicant:Nesher Pharms
Ingredient:dextroamphetamine sulfate
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 206588
Medical Subject Heading (MeSH) Categories for 206588
Suppliers and Packaging for NDA: 206588
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET;ORAL 206588 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-941 68382-941-01 100 TABLET in 1 BOTTLE (68382-941-01)
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET;ORAL 206588 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-942 68382-942-01 100 TABLET in 1 BOTTLE (68382-942-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 28, 2016TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 28, 2016TE:AARLD:No

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