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FDA ANDA · ANDA210559
ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium delayed release capsules
Sponsor: INDCHEMIE HEALTH
APPLICATION
ANDA210559
TYPE
ANDA
ORIGINAL APPROVAL
2021-02-26
LATEST ACTION
2023-05-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription
Products
ESOMEPRAZOLE MAGNESIUMPrescription
ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
ESOMEPRAZOLE MAGNESIUMPrescription
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2023-05-22Labeling · Supplement 6 · standardAP
2023-05-22Labeling · Supplement 3 · standardAP
2021-02-26UNKNOWN · 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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