FDA ANDA · ANDA075189

NABUMETONE

Sponsor: IMPAX LABS INC

APPLICATION

ANDA075189

TYPE

ANDA

ORIGINAL APPROVAL

2000-05-26

LATEST ACTION

2024-11-21

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

NABUMETONEDiscontinued

NABUMETONE 500MG · TABLET · ORAL

NABUMETONEDiscontinued

NABUMETONE 750MG · TABLET · ORAL

2024-11-21Labeling · Supplement 32 · standardAP

2021-04-28Labeling · Supplement 31 · standardAP

2016-05-09Labeling · Supplement 26 · standardAP

2009-11-10Labeling · Supplement 18AP

2006-05-19Labeling · Supplement 16AP

2006-03-17Labeling · Supplement 14AP

2006-03-02Labeling · Supplement 12AP

2002-06-21Manufacturing (CMC) · Supplement 3AP

2002-05-21Labeling · Supplement 4AP

2001-09-24Labeling · Supplement 2 — Letter ↗AP

2001-09-24Manufacturing (CMC) · Supplement 1 — Letter ↗AP

2000-05-26Original — Review ↗AP

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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