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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022165
Company: COSETTE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAMBIA DICLOFENAC POTASSIUM 50MG FOR SOLUTION;ORAL Prescription AB Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/21/2024 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022165s016lbl.pdf
04/23/2024 SUPPL-6 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022165Orig1s006lbl.pdf
04/28/2021 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022165s013s014lbl.pdf
04/28/2021 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022165s013s014lbl.pdf
03/20/2017 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022165s012lbl.pdf
05/09/2016 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022165s011lbl.pdf
06/17/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022165lbl.pdf
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