Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022534
Company: SUN PHARMA GLOBAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOCEFREZ DOCETAXEL 20MG/VIAL INJECTABLE;INJECTION Discontinued None Yes No
DOCEFREZ DOCETAXEL 80MG/VIAL INJECTABLE;INJECTION Discontinued None Yes No
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) SOLUTION;INTRAVENOUS 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
05/03/2011 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022534s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022534s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022534s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022534_docefrez_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022534Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/08/2019 SUPPL-7 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022534s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022534Orig1s007ltr.pdf
05/05/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/03/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/30/2014 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022534s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022534Orig1s004ltr.pdf
06/21/2013 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/13/2012 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022534s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022534Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/08/2019 SUPPL-7 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022534s007lbl.pdf
10/30/2014 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022534s004lbl.pdf
07/13/2012 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022534s002lbl.pdf
05/03/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022534s000lbl.pdf

DOCEFREZ

There are no Therapeutic Equivalents.

DOCETAXEL

SOLUTION;INTRAVENOUS; 20MG/ML (20MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 022534 SUN PHARMA GLOBAL

SOLUTION;INTRAVENOUS; 80MG/4ML (20MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 022534 SUN PHARMA GLOBAL

SOLUTION;INTRAVENOUS; 160MG/8ML (20MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 022534 SUN PHARMA GLOBAL

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