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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022281
Company: RILEY CONSUMER

Other Important Information from FDA

Products on NDA 022281

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZEGERID OTC	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022281

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/01/2009	ORIG-1	Approval	Type 8 - Partial Rx to OTC Switch	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022281lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022281s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022281s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/24/2023	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022281Orig1s017correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022281Orig1s017correctedltr.pdf
12/13/2022	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022281Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022281Orig1s016ltr.pdf
11/01/2022	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022281Orig1s014Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022281Orig1s014ltr.pdf
01/15/2019	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022281Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022281Orig1s013ltr.pdf
10/30/2017	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022281Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022281Orig1s012ltr.pdf
02/17/2017	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022281Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022281Orig1s011ltr.pdf
04/21/2016	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
06/10/2015	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022281s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022281Orig1s008ltr.pdf
11/15/2013	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/18/2012	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022281Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022281Orig1s006ltr.pdf
07/25/2011	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022281Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022281s005ltr.pdf
12/20/2010	SUPPL-3	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022281s003ltr.pdf
12/20/2010	SUPPL-2	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022281s002ltr.pdf
04/15/2010	SUPPL-1	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022281s001ltr.pdf

Labels for NDA 022281

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/24/2023	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022281Orig1s017correctedlbl.pdf
12/13/2022	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022281Orig1s016lbl.pdf
11/01/2022	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022281Orig1s014Lbl.pdf
01/15/2019	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022281Orig1s013lbl.pdf
10/30/2017	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022281Orig1s012lbl.pdf
02/17/2017	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022281Orig1s011lbl.pdf
06/10/2015	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022281s008lbl.pdf
09/18/2012	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022281Orig1s006lbl.pdf
07/25/2011	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022281Orig1s005lbl.pdf
12/01/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022281lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

ZEGERID OTC

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CAPSULE;ORAL; 20MG;1.1GM

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE;ORAL	Over-the-counter	No	204923	AUROBINDO PHARMA
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE;ORAL	Over-the-counter	No	201361	PERRIGO R AND D
OMEPRAZOLE AND SODIUM BICARBONATE	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE;ORAL	Over-the-counter	No	203345	ZYDUS
ZEGERID OTC	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE;ORAL	Over-the-counter	Yes	022281	RILEY CONSUMER

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