APPLICATION
ANDA074190
TYPE
ANDA
ORIGINAL APPROVAL
1994-03-30
LATEST ACTION
2025-02-15
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
NAPROXENPrescription
NAPROXEN 25MG/ML · SUSPENSION · ORAL
Approval history
2025-02-15Labeling · Supplement 19 · standardAP
2021-07-13Labeling · Supplement 16 · standardAP
2021-07-13Labeling · Supplement 17 · standardAP
2019-11-15Labeling · Supplement 14 · standardAP
2019-11-15Labeling · Supplement 15 · standardAP
2019-11-15Labeling · Supplement 13 · standardAP
2015-08-24Labeling · Supplement 11 · standardAP
2007-11-07Labeling · Supplement 10AP
2007-09-25Labeling · Supplement 9AP
2006-08-14Labeling · Supplement 7AP
2003-04-28Labeling · Supplement 5AP
2000-05-24Manufacturing (CMC) · Supplement 4AP
1997-04-30Labeling · Supplement 2AP
1996-08-28Manufacturing (CMC) · Supplement 3AP
1995-01-27Manufacturing (CMC) · Supplement 1AP
1994-03-30OriginalAP
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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