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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050801
Company: QUAGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EVOCLIN CLINDAMYCIN PHOSPHATE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** AEROSOL, FOAM;TOPICAL Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/17/2018 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050801s018lbl.pdf
01/20/2012 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050801s015lbl.pdf
12/21/2010 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050801s011lbl.pdf
07/11/2006 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050801s006lbl.pdf
10/22/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21709lbl.pdf
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