Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021660
Company: ABRAXIS BIOSCIENCE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ABRAXANE PACLITAXEL 100MG/VIAL FOR SUSPENSION;IV (INFUSION) Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/07/2005 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021660lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021660ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21660_AbraxaneTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/24/2016 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

11/02/2015 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

07/21/2015 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021660s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021660Orig1s041ltr.pdf
12/11/2014 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021660s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021660Orig1s040ltr.pdf
04/28/2014 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

10/30/2013 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021660Orig1s038ltr.pdf
09/06/2013 SUPPL-37 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021660Orig1s037ltr.pdf
06/07/2013 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021660Orig1s036ltr.pdf
09/28/2012 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021660s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021660Orig1s034,s035ltr.pdf
09/28/2012 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021660s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021660Orig1s034,s035ltr.pdf
12/10/2012 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

10/11/2012 SUPPL-31 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021660s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021660Orig1s031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021660Orig1s031.pdf
12/23/2011 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021660s025s026s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021660s025,s026,s029ltr.pdf
12/23/2011 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021660s025s026s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021660s025,s026,s029ltr.pdf
12/23/2011 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021660s025s026s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021660s025,s026,s029ltr.pdf
06/26/2009 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021660s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021660s022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021660Orig1s022.pdf
07/01/2008 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021660s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021660s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021660Orig1s013.pdf
02/15/2007 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021660s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021660s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021660Orig1s010.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/21/2015 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021660s041lbl.pdf
12/11/2014 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021660s040lbl.pdf
10/30/2013 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s038lbl.pdf
09/06/2013 SUPPL-37 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s037lbl.pdf
06/07/2013 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s036lbl.pdf
10/11/2012 SUPPL-31 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021660s031lbl.pdf
09/28/2012 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021660s034s035lbl.pdf
09/28/2012 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021660s034s035lbl.pdf
12/23/2011 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021660s025s026s029lbl.pdf
12/23/2011 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021660s025s026s029lbl.pdf
12/23/2011 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021660s025s026s029lbl.pdf
06/26/2009 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021660s022lbl.pdf
07/01/2008 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021660s013lbl.pdf
02/15/2007 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021660s010lbl.pdf
01/07/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021660lbl.pdf

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