An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
OMECLAMOX-PAK	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OMEPRAZOLE	500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL	Discontinued	None	Yes	No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.html 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

Top