Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012806
Company: ALMIRALL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CORDRAN FLURANDRENOLIDE 0.05% OINTMENT;TOPICAL Prescription AT Yes Yes
CORDRAN FLURANDRENOLIDE 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** OINTMENT;TOPICAL Discontinued None Yes No
CORDRAN SP FLURANDRENOLIDE 0.05% CREAM;TOPICAL Prescription AT Yes Yes
CORDRAN SP FLURANDRENOLIDE 0.025% CREAM;TOPICAL Prescription None Yes Yes
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.

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

CORDRAN

OINTMENT;TOPICAL; 0.05%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CORDRAN FLURANDRENOLIDE 0.05% OINTMENT;TOPICAL Prescription Yes AT 012806 ALMIRALL
FLURANDRENOLIDE FLURANDRENOLIDE 0.05% OINTMENT;TOPICAL Prescription No AT 207851 TELIGENT PHARMA INC

CORDRAN SP

CREAM;TOPICAL; 0.05%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CORDRAN SP FLURANDRENOLIDE 0.05% CREAM;TOPICAL Prescription Yes AT 012806 ALMIRALL
FLURANDRENOLIDE FLURANDRENOLIDE 0.05% CREAM;TOPICAL Prescription No AT 205342 CINTEX SVCS

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