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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050824
Company: CUMBERLAND

Safety Labeling Change Order Letter

Summary Review

Products on NDA 050824

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050824

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/08/2011	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050824s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050824s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050824_omeprazole_clarithromycin_amoxicillin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050824Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2024	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050824s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/050824Orig1s013ltr.pdf
08/16/2023	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050824s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050824Orig1s011,012ltr.pdf
08/16/2023	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050824s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050824Orig1s011,012ltr.pdf
03/04/2022	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050824s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050824Orig1s010ltr.pdf
11/27/2020	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050824s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050824Orig1s009ltr.pdf
01/17/2020	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050824s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050824Orig1s007ltr.pdf
10/24/2016	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050824s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050824Orig1s006ltr.pdf
02/26/2016	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/29/2014	SUPPL-4	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050824s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050824Orig1s004ltr.pdf
09/07/2011	SUPPL-3	Labeling		Label is not available on this site.

Labels for NDA 050824

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2024	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050824s013lbl.pdf
08/16/2023	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050824s011s012lbl.pdf
08/16/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050824s011s012lbl.pdf
03/04/2022	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050824s010lbl.pdf
11/27/2020	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050824s009lbl.pdf
01/17/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050824s007lbl.pdf
10/24/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050824s006lbl.pdf
12/29/2014	SUPPL-4	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050824s004lbl.pdf
02/08/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050824s000lbl.pdf

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