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New Drug Application (NDA): 018726
Company: SUN PHARM INDS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
WESTCORT HYDROCORTISONE VALERATE 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT;TOPICAL Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/03/2002 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18726s9s12lbl.pdf
09/03/2002 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18726s9s12lbl.pdf
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