APPLICATION
ANDA204954
TYPE
ANDA
ORIGINAL APPROVAL
2017-01-26
LATEST ACTION
2023-10-13
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued
Products
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 10MG · TABLET, CHEWABLE · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 2.5MG · TABLET, CHEWABLE · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 5MG · TABLET, CHEWABLE · ORAL
Approval history
2023-10-13Labeling · Supplement 4 · standardAP
2021-06-25Labeling · Supplement 3 · standardAP
2017-01-26UNKNOWN · 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.
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