DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (DEXTROAMPHET...
Summary
FDA approved DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) by TAKEDA PHARMS USA. NDA (New Drug) approval (Labeling) on 2026-04-23. CAPSULE, EXTENDED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
NDA021303-40
Action Date
2026-04-23
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (generic: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE), CAPSULE, EXTENDED RELEASE, ORAL. Application: NDA021303
Company
Context & Analysis
TAKEDA PHARMS USA has 13 FDA actions in our database.
Frequently Asked Questions
How often does TAKEDA PHARMS USA have FDA actions?
TAKEDA PHARMS USA has 13 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA021303-40" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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