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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206735

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NDA 206735 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 206735
Tradename:DEXTROAMPHETAMINE SULFATE
Applicant:Mylan Pharms Inc
Ingredient:dextroamphetamine sulfate
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 206735
Medical Subject Heading (MeSH) Categories for 206735
Suppliers and Packaging for NDA: 206735
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 206735 ANDA Mylan Pharmaceuticals Inc. 0378-1070 N 0378-1070-01
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 206735 ANDA Mylan Pharmaceuticals Inc. 0378-1071 N 0378-1071-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Jan 27, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Jan 27, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Jan 27, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
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Chinese Patent Office
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Fuji
Covington
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US Army

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