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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019957
Company: FOUGERA PHARMS

Products on NDA 019957

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CUTIVATE	FLUTICASONE PROPIONATE	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT;TOPICAL	Discontinued	None	Yes	No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 019957

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/1990	ORIG-1	Approval	Type 1 - New Molecular Entity	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
03/19/2021	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019957s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019957Orig1s013ltr.pdf
02/18/2015	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019957s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019957Orig1s012ltr.pdf
01/18/2002	SUPPL-11	Efficacy-New Patient Population	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
06/07/2000	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
12/09/2001	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf
06/30/1999	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/09/2001	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf
11/12/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
06/07/1995	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
10/07/1994	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/07/1994	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/07/1994	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
08/17/1995	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 019957

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/19/2021	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019957s013lbl.pdf
02/18/2015	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019957s012lbl.pdf
01/18/2002	SUPPL-11	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19957s11lbl.pdf
12/09/2001	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf
12/09/2001	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf

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