METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE)
Summary
FDA approved METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) by SPECGX LLC. ANDA (Generic) approval (Labeling) on 2024-08-30. TABLET, EXTENDED RELEASE, ORAL.
Details
Source
Drug Approval
External ID
ANDA202608-17
Action Date
2024-08-30
Status
Approved
Category
drug
Product Code
ANDA (Generic)
Product Description
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (generic: METHYLPHENIDATE HYDROCHLORIDE), TABLET, EXTENDED RELEASE, ORAL. Application: ANDA202608
Company
Context & Analysis
SPECGX LLC has 19 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
How often does SPECGX LLC have FDA actions?
SPECGX LLC has 19 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "ANDA202608-17" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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