Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009112
Company: JOURNEY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EURAX CROTAMITON 10% 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
04/29/1955 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
10/08/2014 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/10/2009 SUPPL-22 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/009112s022ltr.pdf
06/26/2003 SUPPL-21 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-20 Manufacturing (CMC)

Label is not available on this site.

06/05/1987 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/03/1987 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1989 SUPPL-17 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/26/1984 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1984 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/25/1984 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/09/1983 SUPPL-13 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/09/1983 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/15/1983 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/04/1983 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

06/30/1982 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/30/1982 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

06/30/1981 SUPPL-7 Labeling

Label is not available on this site.

09/09/1983 SUPPL-5 Labeling

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-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/06927slr030,09112slr021_eurax_lbl.pdf

EURAX

LOTION;TOPICAL; 10%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CROTAN CROTAMITON 10% LOTION;TOPICAL Prescription No AT 087204 MARNEL PHARMS
EURAX CROTAMITON 10% LOTION;TOPICAL Prescription Yes AT 009112 JOURNEY

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