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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018726
Company: SUN PHARM INDS INC

Products on NDA 018726

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WESTCORT	HYDROCORTISONE VALERATE	0.2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018726

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.

Labels for NDA 018726

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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