APPLICATION
ANDA091601
TYPE
ANDA
ORIGINAL APPROVAL
2010-07-23
LATEST ACTION
2024-05-13
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML · SOLUTION · ORAL
Approval history
2024-05-13Labeling · Supplement 14 · standardAP
2022-09-06Labeling · Supplement 3 · standardAP
2022-09-06Labeling · Supplement 10 · standardAP
2022-09-06Labeling · Supplement 6 · standardAP
2022-09-06Labeling · Supplement 2 · standardAP
2013-09-19Labeling · Supplement 1 · 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.