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FDA ANDA · ANDA207488

METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE

Sponsor: ABHAI LLC

APPLICATION
ANDA207488
TYPE
ANDA
ORIGINAL APPROVAL
2015-06-09
LATEST ACTION
2025-09-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 10MG · TABLET, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 20MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-09-23Labeling · Supplement 18 · standardAP
2021-06-25Labeling · Supplement 8 · standardAP
2021-06-21Labeling · Supplement 7 · standardAP
2015-06-09UNKNOWN · 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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