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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019579
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TERAZOL 7 TERCONAZOLE 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM;VAGINAL Discontinued None Yes No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
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