APPLICATION
ANDA204920
TYPE
ANDA
ORIGINAL APPROVAL
2021-07-20
LATEST ACTION
2025-04-02
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
NAPROXEN AND ESOMEPRAZOLE MAGNESIUMDiscontinued
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE, NAPROXEN 375MG · TABLET, DELAYED RELEASE · ORAL
NAPROXEN AND ESOMEPRAZOLE MAGNESIUMDiscontinued
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE, NAPROXEN 500MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2025-04-02Labeling · Supplement 7 · standardAP
2024-11-21Labeling · Supplement 6 · standardAP
2024-08-15Labeling · Supplement 5 · standardAP
2024-08-15Labeling · Supplement 2 · standardAP
2021-07-20UNKNOWN · 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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