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FDA ANDA · ANDA204470
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
Sponsor: ACTAVIS LABS FL INC
APPLICATION
ANDA204470
TYPE
ANDA
ORIGINAL APPROVAL
2022-08-24
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
NAPROXEN AND ESOMEPRAZOLE MAGNESIUMDiscontinued
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE, NAPROXEN 500MG · TABLET, DELAYED RELEASE · ORAL
NAPROXEN AND ESOMEPRAZOLE MAGNESIUMDiscontinued
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE, NAPROXEN 375MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2024-11-21Labeling · Supplement 4 · standardAP
2024-10-08Labeling · Supplement 3 · standardAP
2022-08-24UNKNOWN · Original · standardAP
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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