Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050824
Company: CUMBERLAND PHARMS
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 CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL Prescription None Yes Yes
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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