Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019579
Company: JANSSEN PHARMS
Company: JANSSEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TERAZOL 7 | TERCONAZOLE | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;VAGINAL | Discontinued | None | Yes | No |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/23/2014 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019579s037,019641s030,019964s032lbl.pdf | |
09/26/2013 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019579s035,019641s028,019964s030lbl.pdf | |
06/30/2004 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19579slr026,19641slr022,19964slr021_terazol_lbl.pdf | |
03/11/2003 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf | |
03/11/2003 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf |