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Chubb
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US Department of Justice
Boehringer Ingelheim
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Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076353

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NDA 076353 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 076353
Tradename:DEXTROAMPHETAMINE SULFATE
Applicant:Specgx Llc
Ingredient:dextroamphetamine sulfate
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076353
Medical Subject Heading (MeSH) Categories for 076353
Suppliers and Packaging for NDA: 076353
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 076353 ANDA SpecGx LLC 0406-8960 N 0406-8960-01
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 076353 ANDA SpecGx LLC 0406-8961 N 0406-8961-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength5MG
Approval Date:May 6, 2003TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:May 6, 2003TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength15MG
Approval Date:May 6, 2003TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Queensland Health
Chubb
Harvard Business School
US Army
Julphar
Fish and Richardson
Moodys
Cerilliant

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