← FDA DRUG APPROVALS

FDA ANDA · ANDA203583

METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE

methylphenidate hydrochloride

Sponsor: SPECGX LLC

APPLICATION

ANDA203583

TYPE

ANDA

ORIGINAL APPROVAL

2015-09-29

LATEST ACTION

2024-10-07

ROUTE

ORAL

DOSAGE FORM

CAPSULE, EXTENDED RELEASE

MARKETING STATUS

Prescription

Products

METHYLPHENIDATE HYDROCHLORIDEPrescription

METHYLPHENIDATE HYDROCHLORIDE 60MG · CAPSULE, EXTENDED RELEASE · ORAL

METHYLPHENIDATE HYDROCHLORIDEPrescription

METHYLPHENIDATE HYDROCHLORIDE 40MG · CAPSULE, EXTENDED RELEASE · ORAL

METHYLPHENIDATE HYDROCHLORIDEPrescription

METHYLPHENIDATE HYDROCHLORIDE 20MG · CAPSULE, EXTENDED RELEASE · ORAL

METHYLPHENIDATE HYDROCHLORIDEPrescription

METHYLPHENIDATE HYDROCHLORIDE 50MG · CAPSULE, EXTENDED RELEASE · ORAL

METHYLPHENIDATE HYDROCHLORIDEPrescription

METHYLPHENIDATE HYDROCHLORIDE 30MG · CAPSULE, EXTENDED RELEASE · ORAL

METHYLPHENIDATE HYDROCHLORIDEPrescription

METHYLPHENIDATE HYDROCHLORIDE 10MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2024-10-07Labeling · Supplement 12 · standardAP

2024-10-07Labeling · Supplement 7 · standardAP

2024-10-07Labeling · Supplement 13 · standardAP

2024-10-07Labeling · Supplement 11 · standardAP

2016-10-28Labeling · Supplement 3 · standardAP

2015-09-29UNKNOWN · Original — Letter ↗AP

VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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