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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040776

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NDA 040776 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 040776

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

Pharmacology for NDA: 040776

Medical Subject Heading (MeSH) Categories for 040776

Suppliers and Packaging for NDA: 040776

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate SOLUTION;ORAL 040776 ANDA FSC Laboratories, Inc 13551-701 13551-701-05 473 mL in 1 BOTTLE (13551-701-05)
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate SOLUTION;ORAL 040776 ANDA Independence Pharmaceuticals, LLC 21724-701 21724-701-05 473 mL in 1 BOTTLE, PLASTIC (21724-701-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/5ML
Approval Date:Jan 29, 2008TE:AARLD:No


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