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FDA ANDA · ANDA205105

METHYLPHENIDATE HYDROCHLORIDE

Sponsor: IMPAX LABS INC

APPLICATION

ANDA205105

TYPE

ANDA

ORIGINAL APPROVAL

2016-07-28

LATEST ACTION

2026-04-21

ROUTE

ORAL

DOSAGE FORM

CAPSULE, EXTENDED RELEASE

MARKETING STATUS

Prescription

Products

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

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

Approval history

2026-04-21Labeling · Supplement 8 · standardAP

2026-04-21Labeling · Supplement 9 · standardAP

2026-04-21Labeling · Supplement 7 · standardAP

2026-04-21Labeling · Supplement 1 · standardAP

2026-04-21Labeling · Supplement 14 · standardAP

2016-07-28UNKNOWN · Original · standardAP

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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