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FDA ANDA · ANDA206582

OMEPRAZOLE

Sponsor: P AND L

APPLICATION
ANDA206582
TYPE
ANDA
ORIGINAL APPROVAL
2020-06-01
LATEST ACTION
2024-10-21
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Over-the-counter

Products

OMEPRAZOLE MAGNESIUMOver-the-counter
OMEPRAZOLE MAGNESIUM EQ 20MG BASE · TABLET, DELAYED RELEASE · ORAL

Approval history

2024-10-21Labeling · Supplement 2 · standardAP
2020-06-01UNKNOWN · Original · standardLetterAP
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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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