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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018751
Company: ALVOGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SPECTAZOLE ECONAZOLE NITRATE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM;TOPICAL Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/21/2020 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018751s025lbl.pdf
09/07/2017 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018751s024lbl.pdf
03/28/2014 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018751s023lbledt.pdf
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