← FDA DRUG APPROVALS

FDA ANDA · ANDA040306

METADATE ER

Sponsor: LANNETT CO INC

APPLICATION
ANDA040306
TYPE
ANDA
ORIGINAL APPROVAL
1999-10-20
LATEST ACTION
2025-10-02
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

METADATE ERDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-10-02Labeling · Supplement 22 · standardAP
2021-06-25Labeling · Supplement 20 · standardAP
2021-06-09Labeling · Supplement 18 · standardAP
2021-06-09Labeling · Supplement 19 · standardAP
2016-01-21Labeling · Supplement 17 · standardAP
2016-01-21Labeling · Supplement 15AP
2016-01-21Labeling · Supplement 13AP
2016-01-21Labeling · Supplement 11AP
2016-01-21Labeling · Supplement 9AP
2016-01-21Labeling · Supplement 16AP
2016-01-21Labeling · Supplement 14AP
2016-01-21Labeling · Supplement 10AP
2005-12-28Labeling · Supplement 8AP
2002-12-09Manufacturing (CMC) · Supplement 3AP
2002-10-09Labeling · Supplement 2AP
2000-05-01Manufacturing (CMC) · Supplement 1AP
1999-10-20Original — 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →