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Generated: October 18, 2017

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 Actavis Elizabeth, Lannett, Nesher Pharms, Able, Mast Mm, Purepac Pharm, Halsey, Novel Labs Inc, Mikart, Mylan Pharms Inc, Mallinckrodt, Mayne Pharma, Tris Pharma Inc, Avanthi Inc, Epic Pharma Llc, Barr, Idt Australia Ltd, Sandoz, Outlook Pharms, Vitarine, Aurolife Pharma Llc, and Vintage Pharms Llc, and is included in twenty-eight 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 NDA: 090652

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 69189-0548-1 1 TABLET in 1 DOSE PACK (69189-0548-1)

Summary for product number 001

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

Summary for product number 002

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


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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Cipla
Cantor Fitzgerald
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McKinsey
Medtronic

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