APPLICATION
ANDA207414
TYPE
ANDA
ORIGINAL APPROVAL
2020-12-16
LATEST ACTION
2024-07-03
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML · SOLUTION · ORAL
Approval history
2024-07-03Labeling · Supplement 2 · standardAP
2024-07-03Labeling · Supplement 1 · standardAP
2020-12-16UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.