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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 209111

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NDA 209111 describes DEXTROAMPHETAMINE SULFATE, which is a drug marketed by Able, Actavis Elizabeth, Anda Repository, Nesher Pharms, Pharmobedient, 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 209111

Tradename:	DEXTROAMPHETAMINE SULFATE
Applicant:	Nesher Pharms
Ingredient:	dextroamphetamine sulfate
Patents:	0

Medical Subject Heading (MeSH) Categories for 209111

Central Nervous System Stimulants
Dopamine Uptake Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	5MG
Approval Date:	Jun 27, 2017	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Jun 27, 2017	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	15MG
Approval Date:	Jun 27, 2017	TE:		RLD:	No

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