Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017765
Company: EPI HLTH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLODERM CLOCORTOLONE PIVALATE 0.1% 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
08/22/1977 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
05/21/2009 SUPPL-26 Labeling-Container/Carton Labels

Label is not available on this site.

02/29/2008 SUPPL-25 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

12/10/2003 SUPPL-24 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17765scp024_cloderm_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17765scp024ltr.pdf
03/14/2002 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/11/2001 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

09/27/2000 SUPPL-21 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/15/1999 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/27/1989 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/17/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/07/1986 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/31/1984 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/01/1983 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/03/1983 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/02/1981 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/31/1980 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/14/1980 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/24/1980 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/24/1980 SUPPL-6 Labeling

Label is not available on this site.

05/08/1980 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/1980 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1980 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/28/1979 SUPPL-2 Labeling

Label is not available on this site.

10/19/1977 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/10/2003 SUPPL-24 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17765scp024_cloderm_lbl.pdf

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