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FDA ANDA · ANDA210139

METHYLPHENIDATE HYDROCHLORIDE

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APPLICATION
ANDA210139
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-03
LATEST ACTION
2024-02-27
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 10MG/5ML · SOLUTION · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL

Approval history

2024-02-27Labeling · Supplement 3 · standardAP
2023-09-12Labeling · Supplement 1 · standardAP
2018-10-03UNKNOWN · Original · standardAP
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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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