APPLICATION
ANDA202807
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-04
LATEST ACTION
2023-09-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Over-the-counter
Products
NAPROXEN SODIUMOver-the-counter
NAPROXEN SODIUM EQ 200MG BASE · CAPSULE · ORAL
Approval history
2023-09-19Labeling · Supplement 8 · standardAP
2023-09-19Labeling · Supplement 7 · standardAP
2020-04-09Labeling · Supplement 3 · standardAP
2020-04-09Labeling · Supplement 2 · standardAP
2019-01-04UNKNOWN · OriginalAP
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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