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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022283
Company: RILEY CONSUMER

Summary Review

Products on NDA 022283

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZEGERID OTC	OMEPRAZOLE; SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022283

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/17/2013	ORIG-1	Approval	Type 8 - Partial Rx to OTC Switch	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022283Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022283Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022283Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022283Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/23/2022	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022283Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022283Orig1s004ltr.pdf
01/15/2019	SUPPL-3	Labeling-Patient Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022283Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022283Orig1s003ltr.pdf
10/30/2017	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022283Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022283Orig1s002ltr.pdf
06/11/2015	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022283Orig1s001bll.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022283Orig1s001ltr.pdf

Labels for NDA 022283

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/23/2022	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022283Orig1s004lbl.pdf
01/15/2019	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022283Orig1s003lbl.pdf
01/15/2019	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022283Orig1s003lbl.pdf
10/30/2017	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022283Orig1s002lbl.pdf
06/11/2015	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022283Orig1s001bll.pdf
06/17/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022283Orig1s000lbl.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.

FOR SUSPENSION;ORAL; 20MG/PACKET;1.68GM/PACKET

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ZEGERID OTC	OMEPRAZOLE; SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Over-the-counter	Yes	022283	RILEY CONSUMER

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