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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 013790
Company: ALMIRALL

Products on NDA 013790

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CORDRAN	FLURANDRENOLIDE	0.05%	LOTION;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 013790

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/19/1963	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
07/27/2011	SUPPL-21	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/013790s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/013790s021ltr.pdf
10/31/2003	SUPPL-18	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/13790scm018ltr.pdf
09/27/2000	SUPPL-17	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/06/1998	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
11/06/1995	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
12/18/1987	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
06/03/1987	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
06/03/1987	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
08/06/1982	SUPPL-10	Labeling		Label is not available on this site.
06/17/1980	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
09/12/1978	SUPPL-8	Labeling		Label is not available on this site.
02/23/1977	SUPPL-7	Labeling		Label is not available on this site.

Labels for NDA 013790

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/27/2011	SUPPL-21	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/013790s021lbl.pdf

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