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FDA ANDA · ANDA209211

DEXMETHYLPHENIDATE HYDROCHLORIDE

Sponsor: CEDIPROF INC

APPLICATION
ANDA209211
TYPE
ANDA
ORIGINAL APPROVAL
2018-09-19
LATEST ACTION
2024-09-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG · TABLET · ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDEPrescription
DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

2024-09-10Labeling · Supplement 3 · standardAP
2023-07-20Labeling · Supplement 2 · standardAP
2018-09-19UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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