Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016455
Company: ALMIRALL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CORDRAN FLURANDRENOLIDE 0.004MG/SQ CM TAPE;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
07/29/1969 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
01/13/2017 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/22/2010 SUPPL-24 Labeling-Container/Carton Labels

Label is not available on this site.

07/19/2000 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/06/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/23/1997 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/18/1987 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1987 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/19/1987 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/20/1985 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/06/1982 SUPPL-12 Labeling

Label is not available on this site.

11/14/1980 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/19/1977 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

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