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FDA ANDA · ANDA213699
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
Sponsor: AJANTA PHARMA LTD
APPLICATION
ANDA213699
TYPE
ANDA
ORIGINAL APPROVAL
2022-10-06
LATEST ACTION
2024-11-22
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
NAPROXEN AND ESOMEPRAZOLE MAGNESIUMPrescription
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE, NAPROXEN 375MG · TABLET, DELAYED RELEASE · ORAL
NAPROXEN AND ESOMEPRAZOLE MAGNESIUMPrescription
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE, NAPROXEN 500MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2024-11-22Labeling · Supplement 6 · standardAP
2024-10-04Labeling · Supplement 3 · standardAP
2022-10-06UNKNOWN · 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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