APPLICATION
ANDA209468
TYPE
ANDA
ORIGINAL APPROVAL
2017-09-25
LATEST ACTION
2023-07-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued
DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG · TABLET · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued
DEXMETHYLPHENIDATE HYDROCHLORIDE 2.5MG · TABLET · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEDiscontinued
DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2023-07-21Labeling · Supplement 4 · standardAP
2021-06-25Labeling · Supplement 3 · standardAP
2019-11-29Labeling · Supplement 2 · standardAP
2017-09-25UNKNOWN · 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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