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FDA ANDA · ANDA217229

METHYLPHENIDATE HYDROCHLORIDE

Sponsor: SUN PHARM INDS INC

APPLICATION
ANDA217229
TYPE
ANDA
ORIGINAL APPROVAL
2023-08-25
LATEST ACTION
2024-04-10
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

METHYLPHENIDATE HYDROCHLORIDEPrescription
METHYLPHENIDATE HYDROCHLORIDE 72MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-04-10Labeling · Supplement 1 · standardAP
2023-08-25UNKNOWN · 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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