APPLICATION
ANDA078873
TYPE
ANDA
ORIGINAL APPROVAL
2012-07-19
LATEST ACTION
2022-10-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 50MG · CAPSULE, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 60MG · CAPSULE, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 40MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2022-10-06Labeling · Supplement 4 · standardAP
2022-10-06Labeling · Supplement 13 · standardAP
2022-10-06Labeling · Supplement 9 · standardAP
2022-10-06Labeling · Supplement 14 · standardAP
2022-10-06Labeling · Supplement 6 · standardAP
2014-01-22Labeling · Supplement 3 · standardAP
2014-01-22Labeling · 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.
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