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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 216266


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NDA 216266 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-one suppliers are listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.
Summary for 216266
Tradename:LISDEXAMFETAMINE DIMESYLATE
Applicant:Prinston Inc
Ingredient:lisdexamfetamine dimesylate
Patents:0
Pharmacology for NDA: 216266
Physiological EffectCentral Nervous System Stimulation
Medical Subject Heading (MeSH) Categories for 216266
Central Nervous System Stimulants
Dopamine Uptake Inhibitors
Suppliers and Packaging for NDA: 216266
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LISDEXAMFETAMINE DIMESYLATE lisdexamfetamine dimesylate CAPSULE;ORAL 216266 ANDA Solco Healthcare US,LLC 43547-602 43547-602-10 100 CAPSULE in 1 BOTTLE (43547-602-10)
LISDEXAMFETAMINE DIMESYLATE lisdexamfetamine dimesylate CAPSULE;ORAL 216266 ANDA Solco Healthcare US,LLC 43547-603 43547-603-10 100 CAPSULE in 1 BOTTLE (43547-603-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Aug 25, 2023TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Aug 25, 2023TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Aug 25, 2023TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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