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FDA ANDA · ANDA207485

METHYLPHENIDATE

methylphenidate hydrochloride

Sponsor: ABHAI LLC

APPLICATION
ANDA207485
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-18
LATEST ACTION
2026-01-09
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

2026-01-09Labeling · Supplement 11 · standardAP
2016-11-18UNKNOWN · 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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