Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013790
Company: ALMIRALL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CORDRAN FLURANDRENOLIDE 0.05% LOTION;TOPICAL Prescription AT 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
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.

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

CORDRAN

LOTION;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% LOTION;TOPICAL Prescription Yes AT 013790 ALMIRALL
FLURANDRENOLIDE FLURANDRENOLIDE 0.05% LOTION;TOPICAL Prescription No AT 205343 CINTEX SVCS
FLURANDRENOLIDE FLURANDRENOLIDE 0.05% LOTION;TOPICAL Prescription No AT 207133 PERRIGO UK FINCO

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