DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (D...
Summary
FDA approved DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) by IMPAX LABS. ANDA (Generic) approval (Labeling) on 2024-08-30. CAPSULE, EXTENDED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
ANDA076852-19
Action Date
2024-08-30
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (generic: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE), CAPSULE, EXTENDED RELEASE, ORAL. Application: ANDA076852
Company
Context & Analysis
IMPAX LABS has 6 FDA actions in our database.
Frequently Asked Questions
How often does IMPAX LABS have FDA actions?
IMPAX LABS has 6 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 "ANDA076852-19" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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