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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 006927
Company: JOURNEY

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EURAX CROTAMITON 10% 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
07/06/1949 ORIG-1 Approval UNKNOWN

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/30/2013 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.
06/26/2003 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06927slr030,09112slr021_eurax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06927slr030,09112slr021ltr.pdf
05/23/2002 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.
03/13/1987 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.
08/25/1989 SUPPL-27 Manufacturing (CMC)-Formulation

Label is not available on this site.
11/26/1984 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.
06/12/1984 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
05/08/1984 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.
03/06/1984 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.
02/04/1983 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
06/30/1982 SUPPL-21 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06927slr030,09112slr021_eurax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06927slr030,09112slr021ltr.pdf
05/28/1982 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
06/04/1981 SUPPL-19 Labeling

Label is not available on this site.
09/09/1983 SUPPL-17 Labeling

Label is not available on this site.
03/12/1979 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
01/10/1980 SUPPL-15 Labeling

Label is not available on this site.
10/05/1978 SUPPL-14 Labeling

Label is not available on this site.
10/27/1977 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/27/1977 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/27/1977 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/27/1977 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/27/1977 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.
11/13/1975 SUPPL-8 Labeling

Label is not available on this site.
11/13/1975 SUPPL-7 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
06/26/2003 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06927slr030,09112slr021_eurax_lbl.pdf
06/30/1982 SUPPL-21 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06927slr030,09112slr021_eurax_lbl.pdf
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