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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 217194

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NDA 217194 describes LISDEXAMFETAMINE DIMESYLATE, which is a drug marketed by Actavis Elizabeth, Alkem Labs Ltd, Amneal, Apotex, Ascent Pharms Inc, Elite Labs Inc, Granules, Hikma, Lannett Co Inc, Mylan, Norwich, Prinston Inc, Rhodes Pharms, Sandoz, Specgx Llc, Sun Pharm Inds Inc, MSN, and Teva Pharms, and is included in twenty-two NDAs. It is available from nineteen suppliers. Additional details are available on the LISDEXAMFETAMINE DIMESYLATE profile page.

The generic ingredient in LISDEXAMFETAMINE DIMESYLATE is lisdexamfetamine dimesylate. Twenty suppliers are listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.

Summary for 217194

Tradename:	LISDEXAMFETAMINE DIMESYLATE
Applicant:	Alkem Labs Ltd
Ingredient:	lisdexamfetamine dimesylate
Patents:	0

Medical Subject Heading (MeSH) Categories for 217194

Central Nervous System Stimulants
Dopamine Uptake Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Aug 25, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	20MG
Approval Date:	Aug 25, 2023	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	Aug 25, 2023	TE:	AB	RLD:	No

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