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FDA NDA · NDA205103

YOSPRALA

Sponsor: GENUS LIFESCIENCES

APPLICATION
NDA205103
TYPE
NDA
ORIGINAL APPROVAL
2016-09-14
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

YOSPRALA · ReferenceDiscontinued
ASPIRIN 325MG, OMEPRAZOLE 40MG · TABLET, DELAYED RELEASE · ORAL
YOSPRALA · ReferenceDiscontinued
ASPIRIN 81MG, OMEPRAZOLE 40MG · TABLET, DELAYED RELEASE · ORAL

Approval history

2024-11-21Labeling · Supplement 10 · standard — Letter ↗AP
2023-07-18Labeling · Supplement 9 · standard — Letter ↗AP
2022-03-04Labeling · Supplement 8 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 7 · standard — Letter ↗AP
2020-11-27Labeling · Supplement 6 · standard — Label ↗AP
2018-06-07Labeling · Supplement 4 · standard — Label ↗AP
2017-10-04Labeling · Supplement 1 · standard — Label ↗AP
2016-09-14Type 4 - New Combination · Original · standard — Letter ↗AP
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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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