Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203551
Company: ACTAVIS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE;INJECTION Prescription AP No No
DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE;INJECTION Prescription AP No No
DOCETAXEL DOCETAXEL 140MG/7ML (20MG/ML) INJECTABLE;INJECTION Prescription None No No
DOCETAXEL DOCETAXEL 160MG/8ML (20MG/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
04/12/2013 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/2013/203551Orig1s000lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203551Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203551_docetaxel_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203551Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/09/2019 SUPPL-7 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203551s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203551Orig1s007ltr.pdf
04/11/2018 SUPPL-5 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203551Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203551Orig1s005ltr.pdf
09/21/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/07/2015 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/17/2014 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203551s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203551Orig1s002ltr.pdf
11/04/2013 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203551s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203551Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/09/2019 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203551s007lbl.pdf
07/09/2019 SUPPL-7 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203551s007lbl.pdf
04/11/2018 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203551Orig1s005lbl.pdf
04/11/2018 SUPPL-5 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203551Orig1s005lbl.pdf
09/17/2014 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203551s002lbl.pdf
11/04/2013 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203551s001lbl.pdf
04/12/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203551Orig1s000lbledt.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 PHARMS CO
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 210327 SHILPA MEDICARE LTD
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 PHARMS CO
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 210327 SHILPA MEDICARE LTD
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 PHARMS CO
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 210327 SHILPA MEDICARE 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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