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FDA ANDA · ANDA089601

METADATE ER

Sponsor: LANNETT CO INC

APPLICATION
ANDA089601
TYPE
ANDA
ORIGINAL APPROVAL
1988-06-01
LATEST ACTION
2025-10-02
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

METADATE ERDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 20MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-10-02Labeling · Supplement 38 · standardAP
2021-06-25Labeling · Supplement 36 · standardAP
2016-01-21Labeling · Supplement 23AP
2016-01-21Labeling · Supplement 28AP
2016-01-21Labeling · Supplement 24AP
2016-01-21Labeling · Supplement 30AP
2016-01-21Labeling · Supplement 27AP
2016-01-21Labeling · Supplement 25AP
2016-01-21Labeling · Supplement 31 · standardAP
2011-08-31Labeling · Supplement 29AP
2005-12-28Labeling · Supplement 22AP
2002-12-09Manufacturing (CMC) · Supplement 17AP
2002-10-09Labeling · Supplement 16AP
2001-10-23Manufacturing (CMC) · Supplement 15AP
1999-11-08Labeling · Supplement 14AP
1999-10-20Labeling · Supplement 12AP
1999-02-22Manufacturing (CMC) · Supplement 10AP
1998-12-08Manufacturing (CMC) · Supplement 9AP
1998-12-08Manufacturing (CMC) · Supplement 8AP
1998-02-13Labeling · Supplement 7AP
1996-07-02Labeling · Supplement 6AP
1995-09-11Manufacturing (CMC) · Supplement 5AP
1994-08-25Manufacturing (CMC) · Supplement 4AP
1994-01-21Manufacturing (CMC) · Supplement 3AP
1988-06-01Original — Other Important Information from FDA ↗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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