APPLICATION
ANDA206497
TYPE
ANDA
ORIGINAL APPROVAL
2022-03-14
LATEST ACTION
2026-07-22
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
METHYLPHENIDATEPrescription
METHYLPHENIDATE 20MG/9HR (2.2MG/HR) · FILM, EXTENDED RELEASE · TRANSDERMAL
METHYLPHENIDATEPrescription
METHYLPHENIDATE 10MG/9HR (1.1MG/HR) · FILM, EXTENDED RELEASE · TRANSDERMAL
METHYLPHENIDATEPrescription
METHYLPHENIDATE 30MG/9HR (3.3MG/HR) · FILM, EXTENDED RELEASE · TRANSDERMAL
METHYLPHENIDATEPrescription
METHYLPHENIDATE 15MG/9HR (1.6MG/HR) · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2026-07-22Labeling · Supplement 5 · standardAP
2026-07-22Labeling · Supplement 7 · standardAP
2024-08-30Labeling · Supplement 2 · 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.
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