Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020766
Company: CHEPLAPHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XENICAL ORLISTAT 120MG CAPSULE;ORAL Prescription None Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/07/2015 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020766s035lbl.pdf
10/16/2013 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020766s033lbl.pdf
10/16/2013 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020766s033lbl.pdf
10/16/2013 SUPPL-33 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020766s033lbl.pdf
01/20/2012 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020766s029lbl.pdf
01/20/2012 SUPPL-29 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020766s029lbl.pdf
12/17/2010 SUPPL-30 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020766s030lbl.pdf
05/25/2010 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020766s028lbl.pdf
02/11/2009 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020766s026lbl.pdf
01/05/2007 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020766s022lbl.pdf
09/02/2005 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020766s021lbl.pdf
10/22/2004 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20766s019lbl.pdf
07/09/2004 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20766slr020_xenical_lbl.pdf
12/12/2003 SUPPL-18 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20766se5-018_xenical_lbl.pdf
06/25/2001 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20766s7lbl.pdf
04/23/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20766lbl.pdf

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