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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018707
Company: FOUGERA PHARMS

Products on NDA 018707

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACLOVATE	ALCLOMETASONE DIPROPIONATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM;TOPICAL	Discontinued	None	Yes	No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 018707

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/1982	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
04/05/2011	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018707s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018707s012,018702s011ltr.pdf
06/03/2002	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
04/02/2003	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18707slr008,18702slr007ltr.pdf
04/26/1996	SUPPL-7	Efficacy-New Patient Population		Label is not available on this site.
06/22/1994	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
06/07/1994	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/08/1990	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/20/1986	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
11/03/1983	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 018707

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2011	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018707s012lbl.pdf
04/02/2003	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf

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