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FDA ANDA · ANDA202608

METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE

methylphenidate hydrochloride

Sponsor: SPECGX LLC

APPLICATION
ANDA202608
TYPE
ANDA
ORIGINAL APPROVAL
2012-12-28
LATEST ACTION
2024-08-30
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 54MG · TABLET, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 27MG · TABLET, EXTENDED RELEASE · ORAL
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 36MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-08-30Labeling · Supplement 17 · standardAP
2024-08-30Labeling · Supplement 9 · standardAP
2024-08-30Labeling · Supplement 18 · standardAP
2016-10-28Labeling · Supplement 7 · standardAP
2016-10-28Labeling · Supplement 6 · standardAP
2016-10-28Labeling · Supplement 4 · standardAP
2012-12-28UNKNOWN · Original — Review ↗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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