Last Updated: September 24, 2026

Details for New Drug Application (NDA): 213763

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NDA 213763 describes AMPHETAMINE SULFATE, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aurolife Pharma Llc, Bionpharma, Dr Reddys Labs Sa, Epic Pharma Llc, Glenmark Pharms Ltd, Granules, Ingenus Pharms Llc, Lannett, Prinston Inc, Rhodes Pharms, Sanaluz, Senores Pharms, Specgx Llc, and Sun Pharm Inds Inc, and is included in sixteen NDAs. It is available from ten suppliers. Additional details are available on the AMPHETAMINE SULFATE profile page.

The generic ingredient in AMPHETAMINE SULFATE is amphetamine sulfate. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.

Summary for 213763

Tradename:	AMPHETAMINE SULFATE
Applicant:	Ingenus Pharms Llc
Ingredient:	amphetamine sulfate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Aug 24, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Aug 24, 2020	TE:		RLD:	No

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