DEXMETHYLPHENIDATE HYDROCHLORIDE
Summary
FDA approved DEXMETHYLPHENIDATE HYDROCHLORIDE by AUROLIFE PHARMA LLC. ANDA (Generic) approval (Labeling) on 2026-03-19. CAPSULE, EXTENDED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
ANDA202580-8
Action Date
2026-03-19
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
DEXMETHYLPHENIDATE HYDROCHLORIDE, CAPSULE, EXTENDED RELEASE, ORAL. Application: ANDA202580
Company
Context & Analysis
AUROLIFE PHARMA LLC has 10 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
How often does AUROLIFE PHARMA LLC have FDA actions?
AUROLIFE PHARMA LLC has 10 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "ANDA202580-8" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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