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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021636
Company: SALIX

Medication Guide

Other Important Information from FDA

Products on NDA 021636

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZEGERID	OMEPRAZOLE; SODIUM BICARBONATE	20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No
ZEGERID	OMEPRAZOLE; SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021636

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/2004	ORIG-1	Approval	Type 3 - New Dosage Form and Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21636_zegerid_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21636ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021636s000_ZegeridTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2023	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021849s020,021636s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021636Orig1s025;021849Orig1s020ltr.pdf
03/04/2022	SUPPL-24	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021849s019,021636s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021636Orig1s024; 021849Orig1s019ltr.pdf
11/27/2020	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021636s022,021849s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021636Orig1s022;021849Orig1s016ltr.pdf
09/24/2019	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021636s020,021849s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021636Orig1s020, 021849Orig1s015ltr.pdf
06/07/2018	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021849s014,021636s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021849Orig1s014,021636Orig1s019ltr.pdf
10/24/2016	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021636s017,021849s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021849Orig1s012,021636Orig1s017ltr.pdf
12/19/2014	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021849s010021636s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021636Orig1s016,021849Orig1s010ltr.pdf
02/25/2014	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021636s015,021849s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021636Orig1s015,021849Orig1s009ltr.pdf
12/20/2013	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/19/2012	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s013,021849s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021636s013,021849s008ltr.pdf
11/09/2012	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s012,021849s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021636Orig1s012,021849Orig1s007ltr.pdf
12/07/2011	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s011,021849s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021636s011,021849s006ltr.pdf
05/20/2011	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s010,021849s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021636s010,021849s005ltr.pdf
09/03/2010	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,021850s003,022456s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s009,021849s004,021850s003,022456s002ltr.pdf
01/20/2010	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s008,021849s003,021850s002ltr.pdf

Labels for NDA 021636

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2023	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021849s020,021636s025lbl.pdf
03/04/2022	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021849s019,021636s024lbl.pdf
03/04/2022	SUPPL-24	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021849s019,021636s024lbl.pdf
11/27/2020	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021636s022,021849s016lbl.pdf
09/24/2019	SUPPL-20	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021636s020,021849s015lbl.pdf
09/24/2019	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021636s020,021849s015lbl.pdf
06/07/2018	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021849s014,021636s019lbl.pdf
06/07/2018	SUPPL-19	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021849s014,021636s019lbl.pdf
10/24/2016	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021636s017,021849s012lbl.pdf
12/19/2014	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021849s010021636s016lbl.pdf
12/19/2014	SUPPL-16	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021849s010021636s016lbl.pdf
02/25/2014	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021636s015,021849s009lbl.pdf
11/09/2012	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s012,021849s007lbl.pdf
04/19/2012	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021636s013,021849s008lbl.pdf
12/07/2011	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s011,021849s006lbl.pdf
05/20/2011	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021636s010,021849s005lbl.pdf
09/03/2010	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,021850s003,022456s002lbl.pdf
01/20/2010	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s008lbl.pdf
06/15/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21636_zegerid_lbl.pdf

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