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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017950
Company: SUN PHARM INDS INC

Products on NDA 017950

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WESTCORT	HYDROCORTISONE VALERATE	0.2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017950

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.

Labels for NDA 017950

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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