Drugs@FDA: FDA-Approved Drugs

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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WESTCORT HYDROCORTISONE VALERATE 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT;TOPICAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/08/1983 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/03/2002 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18726s9s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18726slr012,009ltr.pdf
09/03/2002 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18726s9s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18726slr012,009ltr.pdf
02/22/1993 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1991 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/03/1985 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1984 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/27/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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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