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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012806
Company: ALMIRALL

Products on NDA 012806

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CORDRAN	FLURANDRENOLIDE	0.05%	OINTMENT;TOPICAL	Discontinued	None	Yes	No
CORDRAN	FLURANDRENOLIDE	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT;TOPICAL	Discontinued	None	Yes	No
CORDRAN SP	FLURANDRENOLIDE	0.05%	CREAM;TOPICAL	Discontinued	None	Yes	No
CORDRAN SP	FLURANDRENOLIDE	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM;TOPICAL	Discontinued	None	Yes	No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 012806

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/18/1965	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
07/23/2013	SUPPL-37	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012806s037lbl.pdf
06/12/2013	SUPPL-36	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012806Orig1s036ltr.pdf
12/14/2012	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
03/25/2008	SUPPL-32	Labeling-Container/Carton Labels		Label is not available on this site.
07/17/2002	SUPPL-28	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12806scm028ltr.pdf
11/06/1998	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
08/30/1991	SUPPL-26	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/02/1990	SUPPL-25	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/18/1987	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
06/03/1987	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
11/14/1986	SUPPL-22	Labeling		Label is not available on this site.
10/08/1982	SUPPL-21	Labeling		Label is not available on this site.
08/12/1980	SUPPL-20	Labeling		Label is not available on this site.
11/26/1979	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
06/30/1978	SUPPL-17	Labeling		Label is not available on this site.
07/24/1978	SUPPL-16	Labeling		Label is not available on this site.
12/14/1977	SUPPL-15	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
02/23/1977	SUPPL-14	Labeling		Label is not available on this site.
11/11/1977	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 012806

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/23/2013	SUPPL-37	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012806s037lbl.pdf

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