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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009112
Company: JOURNEY

Products on NDA 009112

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EURAX	CROTAMITON	10%	LOTION;TOPICAL	Prescription	AT	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 009112

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.

Labels for NDA 009112

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

Therapeutic Equivalents for NDA 009112

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	LEGACY PHARMA
EURAX	CROTAMITON	10%	LOTION;TOPICAL	Prescription	Yes	AT	009112	JOURNEY

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