Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 201525
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOCETAXEL DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE;INJECTION Prescription AP No No
DOCETAXEL DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE;INJECTION Prescription AP No No
DOCETAXEL DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE;INJECTION Prescription AP 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
06/29/2011 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201525s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201525s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201525_docetaxel_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201525Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/27/2019 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201525s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201525Orig1s016, 201525Orig1s017ltr.pdf
03/27/2019 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201525s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201525Orig1s016, 201525Orig1s017ltr.pdf
10/21/2016 SUPPL-12 Labeling-Package Insert Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201525Orig1s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/201525Orig1s012.pdf
07/25/2016 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/04/2014 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201525Orig1s008,s009ltr.pdf
11/04/2014 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201525Orig1s008,s009ltr.pdf
08/18/2014 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/23/2014 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201525Orig1s003ltr.pdf
03/15/2012 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201525s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201525s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/27/2019 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201525s016s017lbl.pdf
03/27/2019 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201525s016s017lbl.pdf
11/04/2014 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s008s009lbl.pdf
11/04/2014 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s008s009lbl.pdf
04/23/2014 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s003lbl.pdf
03/15/2012 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201525s002lbl.pdf
06/29/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201525s000lbl.pdf

DOCETAXEL

INJECTABLE;INJECTION; 20MG/2ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOCETAXEL DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE;INJECTION Prescription Yes AP 022234 HOSPIRA INC
DOCETAXEL DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 207563 INGENUS PHARMS LLC
DOCETAXEL DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 210072 MYLAN LABS LTD
DOCETAXEL DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 201525 SANDOZ

INJECTABLE;INJECTION; 80MG/8ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOCETAXEL DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE;INJECTION Prescription Yes AP 022234 HOSPIRA INC
DOCETAXEL DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 207563 INGENUS PHARMS LLC
DOCETAXEL DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 210848 MYLAN LABS LTD
DOCETAXEL DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 201525 SANDOZ

INJECTABLE;INJECTION; 160MG/16ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOCETAXEL DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE;INJECTION Prescription Yes AP 022234 HOSPIRA INC
DOCETAXEL DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 207563 INGENUS PHARMS LLC
DOCETAXEL DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 208859 MYLAN LABS LTD
DOCETAXEL DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE;INJECTION Prescription No AP 201525 SANDOZ

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