Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022165
Company: ASSERTIO
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/17/2009 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/2009/022165lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022165s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022165s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022165s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/20/2017 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022165s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022165Orig1s012ltr.pdf
05/09/2016 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022165s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022165Orig1s011ltr.pdf
12/10/2015 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/30/2014 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/20/2011 SUPPL-4 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022165s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

CAMBIA

FOR SOLUTION;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CAMBIA DICLOFENAC POTASSIUM 50MG FOR SOLUTION;ORAL Prescription Yes AB 022165 ASSERTIO
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG FOR SOLUTION;ORAL Prescription No AB 202964 PAR FORM

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