Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017950
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WESTCORT HYDROCORTISONE VALERATE 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CREAM;TOPICAL Discontinued None Yes No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
03/17/1978 ORIG-1 Approval Type 2 - New Active Ingredient 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
03/24/2003 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17950slr021_westcort_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17950slr021ltr.pdf
11/29/1991 SUPPL-19 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/04/1988 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1986 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1985 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/03/1985 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1984 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/05/1983 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/06/1983 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1982 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/27/1981 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/28/1983 SUPPL-9 Labeling

Label is not available on this site.

09/08/1982 SUPPL-8 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/14/1980 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1980 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

01/10/1980 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/10/1979 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/1978 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/1979 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/24/2003 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17950slr021_westcort_lbl.pdf

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