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Last Updated: March 26, 2026

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, Nesher Pharms, Pharmobedient, Senores Pharms, Specgx Llc, Strides Pharma, Strides Pharma Intl, Prasco, Tris Pharma Inc, Ani Pharms, Aurolife Pharma Llc, Avanthi Inc, Azurity, Barr, Epic Pharma Llc, Halsey, Lannett, Mast Mm, Novel Labs Inc, Nuvo Pharm, Purepac Pharm, Sandoz, Vitarine, and Winder Labs Llc, and is included in thirty-three NDAs. It is available from fourteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the dextroamphetamine sulfate profile page.
Summary for 040776
Tradename:DEXTROAMPHETAMINE SULFATE
Applicant:Prasco
Ingredient:dextroamphetamine sulfate
Patents:0
Pharmacology for NDA: 040776
Physiological EffectCentral Nervous System Stimulation
Medical Subject Heading (MeSH) Categories for 040776
Central Nervous System Stimulants
Dopamine Uptake Inhibitors
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 INDEPENDENCE PHARMACEUTICALS, LLC 21724-701 21724-701-05 473 mL in 1 BOTTLE, PLASTIC (21724-701-05)
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate SOLUTION;ORAL 040776 ANDA Prasco Laboratories 66993-359 66993-359-57 473 mL in 1 BOTTLE, PLASTIC (66993-359-57)

Profile for product number 001

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

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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