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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019958
Company: FOUGERA PHARMS

Products on NDA 019958

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CUTIVATE	FLUTICASONE PROPIONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM;TOPICAL	Discontinued	None	Yes	No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 019958

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/18/1990	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
09/03/2010	SUPPL-17	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019958s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019958s017ltr.pdf
06/07/2000	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
04/16/2002	SUPPL-13	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19958s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19958s13ltr.pdf
01/21/1999	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
06/17/1999	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19957s11lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19957s11ltr.pdf
08/08/1997	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
04/25/1997	SUPPL-9	Efficacy-New Patient Population		Label is not available on this site.
06/17/1999	SUPPL-8	Efficacy-New Patient Population	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/19958s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19958s08ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19958S8_Cutivate.cfm
06/07/1995	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
10/07/1994	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
06/07/1994	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/07/1994	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
02/14/1991	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
02/14/1991	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 019958

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/03/2010	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019958s017lbl.pdf
04/16/2002	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19958s13lbl.pdf
06/17/1999	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19957s11lbl.pdf
06/17/1999	SUPPL-8	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/19958s8lbl.pdf

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