Last Updated: September 24, 2026

Details for New Drug Application (NDA): 083901

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NDA 083901 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 083901

Tradename:	AMPHETAMINE SULFATE
Applicant:	Lannett
Ingredient:	amphetamine sulfate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 31, 1984	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 31, 1984	TE:		RLD:	Yes

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