Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202964
Company: PAR FORM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG FOR SOLUTION;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/02/2016 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202964Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202964Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/02/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202964Orig1s000lbl.pdf

DICLOFENAC POTASSIUM

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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