Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018738
Company: JOURNEY
Company: JOURNEY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EXELDERM | SULCONAZOLE NITRATE | 1% | SOLUTION;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 |
---|---|---|---|---|---|---|---|
08/30/1985 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018738Orig1s000rev.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/19/2014 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/08/2009 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018738s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018738s009ltr.pdf | |
10/19/2001 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/30/2003 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18737slr003_exelderm_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18738slr007ltr.pdf | |
09/22/1993 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/08/1991 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/14/1991 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
07/20/1990 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/20/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
12/18/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/08/2009 | SUPPL-9 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018738s009lbl.pdf | |
05/30/2003 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18737slr003_exelderm_lbl.pdf |