Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103976
Company: GENENTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XOLAIR OMALIZUMAB 150MG/VIAL VIAL Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/20/2003 ORIG-1 Approval N/A Label (PDF)
Letter
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/omalgen062003LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/omalgen062003L.htm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/01/2019 SUPPL-5234 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103976s5234lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103976Orig1s5234ltr.pdf
09/28/2018 SUPPL-5231 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103976s5231lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103976Orig1s5231ltr.pdf
07/06/2016 SUPPL-5225 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103976s5225lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103976Orig1s5225ltr.pdf
12/03/2015 SUPPL-5224 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103976s5224lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103976Orig1s5224ltr.pdf
03/21/2014 SUPPL-5211 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103976s5211lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103976Orig1s5211ltr.pdf
12/22/2011 SUPPL-5191 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103976s5191ltr.pdf
12/21/2010 SUPPL-5180 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103976s5180ltr.pdf
01/04/2010 SUPPL-5166 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103976s5166ltr.pdf
07/30/2010 SUPPL-5165 Supplement

Label is not available on this site.

09/26/2014 SUPPL-5161 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103976s5161lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103976Orig1s5161ltr.pdf
07/24/2009 SUPPL-5154 Supplement

Label is not available on this site.

07/02/2007 SUPPL-5102 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103976s5102lbl.pdf
04/07/2006 SUPPL-5087 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103976s5097lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103976s5097ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/01/2019 SUPPL-5234 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103976s5234lbl.pdf
09/28/2018 SUPPL-5231 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103976s5231lbl.pdf
07/06/2016 SUPPL-5225 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103976s5225lbl.pdf
12/03/2015 SUPPL-5224 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103976s5224lbl.pdf
09/26/2014 SUPPL-5161 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103976s5161lbl.pdf
03/21/2014 SUPPL-5211 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103976s5211lbl.pdf
07/02/2007 SUPPL-5102 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103976s5102lbl.pdf
04/07/2006 SUPPL-5087 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103976s5097lbl.pdf
06/20/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/omalgen062003LB.pdf

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