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Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203901

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NDA 203901 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 203901
Tradename:DEXTROAMPHETAMINE SULFATE
Applicant:Actavis Elizabeth
Ingredient:dextroamphetamine sulfate
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203901
Medical Subject Heading (MeSH) Categories for 203901
Suppliers and Packaging for NDA: 203901
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 203901 ANDA Actavis Pharma, Inc. 45963-303 45963-303-09 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-303-09)
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 203901 ANDA Actavis Pharma, Inc. 45963-304 45963-304-09 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-304-09)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Nov 30, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Nov 30, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Nov 30, 2012TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Citi
Cerilliant
Covington
Fish and Richardson
Argus Health
McKesson
US Army
McKinsey

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