Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 201195
Company: ACCORD HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOCETAXEL DOCETAXEL 20MG/0.5ML (40MG/ML) INJECTABLE;INJECTION Discontinued None Yes No
DOCETAXEL DOCETAXEL 80MG/2ML (40MG/ML) INJECTABLE;INJECTION Discontinued None Yes No
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription AP Yes No
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription AP Yes No
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription AP 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
06/08/2011 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/2011/201195s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201195s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201195_docetaxel_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201195Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/21/2019 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201195s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201195Orig1s013ltr.pdf
07/26/2016 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201195s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201195Orig1s009ltr.pdf
10/21/2015 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/27/2016 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/03/2014 SUPPL-6 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201195s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201195Orig1s006ltr.pdf
11/06/2013 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/05/2013 SUPPL-4 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201195s004lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/21/2019 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201195s013lbl.pdf
07/26/2016 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201195s009lbl.pdf
07/03/2014 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201195s006lbl.pdf
07/03/2014 SUPPL-6 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201195s006lbl.pdf
04/05/2013 SUPPL-4 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201195s004lbl.pdf
06/08/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201195s000lbl.pdf

DOCETAXEL

INJECTABLE;INJECTION; 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) INJECTABLE;INJECTION Prescription Yes AP 201195 ACCORD HLTHCARE
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203551 ACTAVIS LLC
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 209640 AMNEAL
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 206177 DFB ONCOLOGY LTD
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 204193 DR REDDYS LABS LTD
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 207252 JIANGSU HENGRUI MED
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 205934 TEIKOKU PHARMA
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203877 TEVA PHARMS USA
TAXOTERE DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020449 SANOFI AVENTIS US

INJECTABLE;INJECTION; 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) INJECTABLE;INJECTION Prescription Yes AP 201195 ACCORD HLTHCARE
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203551 ACTAVIS LLC
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 209640 AMNEAL
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 206177 DFB ONCOLOGY LTD
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 204193 DR REDDYS LABS LTD
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 207252 JIANGSU HENGRUI MED
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 205934 TEIKOKU PHARMA
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203877 TEVA PHARMS USA
TAXOTERE DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020449 SANOFI AVENTIS US

INJECTABLE;INJECTION; 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) INJECTABLE;INJECTION Prescription Yes AP 201195 ACCORD HLTHCARE
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203551 ACTAVIS LLC
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 209640 AMNEAL
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 207252 JIANGSU HENGRUI MED
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 208137 MYLAN LABS LTD
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 205934 TEIKOKU PHARMA
TAXOTERE DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020449 SANOFI AVENTIS US

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