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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 212919

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NDA 212919 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, Lannett, Novast Labs, 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 are fifty-five drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.

Summary for 212919

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Nov 22, 2019	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Nov 22, 2019	TE:	AA	RLD:	No

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