APPLICATION
ANDA204602
TYPE
ANDA
ORIGINAL APPROVAL
2015-08-14
LATEST ACTION
2025-06-03
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML · SOLUTION · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL
Approval history
2025-06-03Labeling · Supplement 6 · standardAP
2025-06-03Labeling · Supplement 5 · standardAP
2025-06-03Labeling · Supplement 3 · standardAP
2015-08-14UNKNOWN · OriginalAP
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.
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