Drugs@FDA: FDA-Approved Drugs
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 | LEGACY PHARMA |
EURAX | CROTAMITON | 10% | LOTION;TOPICAL | Prescription | Yes | AT | 009112 | JOURNEY |