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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 205077

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NDA 205077 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 205077

Tradename:	DEXTROAMPHETAMINE SULFATE
Applicant:	Strides Pharma
Ingredient:	dextroamphetamine sulfate
Patents:	0

Medical Subject Heading (MeSH) Categories for 205077

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 21, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Jun 21, 2019	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	15MG
Approval Date:	Jun 21, 2019	TE:		RLD:	No

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