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FDA ANDA · ANDA079031
METHYLPHENIDATE HYDROCHLORIDE (LA)
methylphenidate hydrochloride
Sponsor: BARR LABS INC
APPLICATION
ANDA079031
TYPE
ANDA
ORIGINAL APPROVAL
2012-07-13
LATEST ACTION
2024-10-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 10MG · CAPSULE, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 30MG · CAPSULE, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 40MG · CAPSULE, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 20MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2024-10-01Labeling · Supplement 15 · standardAP
2023-04-19Labeling · Supplement 10 · standardAP
2023-04-19Labeling · Supplement 6 · standardAP
2023-04-19Labeling · Supplement 7 · standardAP
2023-04-19Labeling · Supplement 14 · standardAP
2023-04-19Labeling · Supplement 8 · standardAP
2014-10-15OriginalAP
2012-07-13OriginalAP
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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