APPLICATION
ANDA074201
TYPE
ANDA
ORIGINAL APPROVAL
1993-12-21
LATEST ACTION
2015-07-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NAPROXENPrescription
NAPROXEN 500MG · TABLET · ORAL
NAPROXENPrescription
NAPROXEN 250MG · TABLET · ORAL
NAPROXENPrescription
NAPROXEN 375MG · TABLET · ORAL
Approval history
2015-07-13Labeling · Supplement 39 · standardAP
2015-07-13Labeling · Supplement 38 · standardAP
2015-07-13Labeling · Supplement 40 · standardAP
2009-03-11Labeling · Supplement 30AP
2008-06-28Labeling · Supplement 31AP
2006-02-17Labeling · Supplement 26AP
2001-10-22Manufacturing (CMC) · Supplement 17AP
2001-10-22Manufacturing (CMC) · Supplement 18AP
2000-12-13Manufacturing (CMC) · Supplement 16AP
2000-08-28Manufacturing (CMC) · Supplement 14AP
1999-12-02Manufacturing (CMC) · Supplement 13AP
1999-12-02Manufacturing (CMC) · Supplement 12AP
1999-02-12Manufacturing (CMC) · Supplement 7AP
1999-02-12Manufacturing (CMC) · Supplement 6AP
1996-10-29Manufacturing (CMC) · Supplement 4AP
1996-08-16Manufacturing (CMC) · Supplement 5AP
1996-03-13Labeling · Supplement 3AP
1995-01-27Manufacturing (CMC) · Supplement 2AP
1994-10-21Manufacturing (CMC) · Supplement 1AP
1993-12-21OriginalAP
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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