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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205103
Company: GENUS LIFESCIENCES

Medication Guide

Products on NDA 205103

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
YOSPRALA	ASPIRIN; OMEPRAZOLE	81MG;40MG	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	Yes	No
YOSPRALA	ASPIRIN; OMEPRAZOLE	325MG;40MG	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205103

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/14/2016	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205103s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205103Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/205103Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2023	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205103s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205103Orig1s009ltr.pdf
03/04/2022	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205103s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205103Orig1s008ltr.pdf
04/28/2021	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205103s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205103Orig1s007ltr.pdf
11/27/2020	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205103s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205103Orig1s006ltr.pdf
06/07/2018	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205103s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205103Orig1s004ltr.pdf
10/04/2017	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205103s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205103Origs001ltr.pdf

Labels for NDA 205103

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2023	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205103s009lbl.pdf
03/04/2022	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205103s008lbl.pdf
04/28/2021	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205103s007lbl.pdf
04/28/2021	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205103s007lbl.pdf
11/27/2020	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205103s006lbl.pdf
11/27/2020	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205103s006lbl.pdf
06/07/2018	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205103s004lbl.pdf
06/07/2018	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205103s004lbl.pdf
10/04/2017	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205103s001lbl.pdf
10/04/2017	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205103s001lbl.pdf
09/14/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205103s000lbl.pdf

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