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FDA ANDA · ANDA205327

METHYLPHENIDATE HYDROCHLORIDE

Sponsor: OSMOTICA PHARM US

APPLICATION

ANDA205327

TYPE

ANDA

ORIGINAL APPROVAL

2017-07-28

LATEST ACTION

2024-01-11

ROUTE

ORAL

DOSAGE FORM

TABLET, EXTENDED RELEASE

MARKETING STATUS

Prescription

Products

METHYLPHENIDATE HYDROCHLORIDEPrescription

METHYLPHENIDATE HYDROCHLORIDE 54MG · TABLET, EXTENDED RELEASE · ORAL

METHYLPHENIDATE HYDROCHLORIDEPrescription

METHYLPHENIDATE HYDROCHLORIDE 27MG · TABLET, EXTENDED RELEASE · ORAL

METHYLPHENIDATE HYDROCHLORIDEPrescription

METHYLPHENIDATE HYDROCHLORIDE 72MG · TABLET, EXTENDED RELEASE · ORAL

METHYLPHENIDATE HYDROCHLORIDEPrescription

METHYLPHENIDATE HYDROCHLORIDE 36MG · TABLET, EXTENDED RELEASE · ORAL

METHYLPHENIDATE HYDROCHLORIDEPrescription

METHYLPHENIDATE HYDROCHLORIDE 18MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-01-11Labeling · Supplement 16 · standardAP

2024-01-11Labeling · Supplement 20 · standardAP

2018-05-21Labeling · Supplement 7 · standardAP

2017-07-28UNKNOWN · Original · standard — Letter ↗AP

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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