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New Drug Application (NDA): 016131
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOMID CLOMIPHENE CITRATE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/18/2017 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016131s028lbl.pdf
10/22/2012 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016131s026lbl.pdf
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