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Last Updated: December 4, 2022

Dextroamphetamine sulfate - Generic Drug Details


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What are the generic drug sources for dextroamphetamine sulfate and what is the scope of freedom to operate?

Dextroamphetamine sulfate is the generic ingredient in five branded drugs marketed by Impax Labs Inc, Able, Actavis Elizabeth, Mayne Pharma, Mylan, Nesher Pharms, Specgx Llc, Strides Pharma, Teva, Glaxosmithkline, Outlook Pharms, Tris Pharma Inc, Ani Pharms, Arbor Pharms Llc, Aurolife Pharma Llc, Avanthi Inc, Barr, Epic Pharma Llc, Halsey, Lannett, Mast Mm, Novel Labs Inc, Nuvo Pharm, Purepac Pharm, Sandoz, Vitarine, Winder Labs Llc, Shire, and Ferndale Labs, and is included in forty NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for dextroamphetamine sulfate. Sixteen suppliers are listed for this compound.

Drug Prices for dextroamphetamine sulfate

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Recent Clinical Trials for dextroamphetamine sulfate

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SponsorPhase
Vallon Pharmaceuticals, Inc.Phase 1
Medical University of ViennaN/A
Centre hospitalier de l'Université de Montréal (CHUM)Phase 2

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Pharmacology for dextroamphetamine sulfate
Medical Subject Heading (MeSH) Categories for dextroamphetamine sulfate

US Patents and Regulatory Information for dextroamphetamine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lannett DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate TABLET;ORAL 083903-003 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Strides Pharma DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 205673-002 Oct 31, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glaxosmithkline DEXEDRINE dextroamphetamine sulfate TABLET;ORAL 084935-001 Approved Prior to Jan 1, 1982 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mayne Pharma DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 076137-002 Jan 18, 2002 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 206735-001 Jan 27, 2016 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actavis Elizabeth DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 203901-002 Nov 30, 2012 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Able DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 076814-003 Aug 25, 2004 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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