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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203551
Company: ACTAVIS

Summary Review

Products on NDA 203551

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203551

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
07/27/2020	SUPPL-9	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203551s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203551Orig1s009ltr.pdf
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

Labels for NDA 203551

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/27/2020	SUPPL-9	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203551s009lbl.pdf
07/27/2020	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203551s009lbl.pdf
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

Therapeutic Equivalents for NDA 203551

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	216677	ACIC PHARMS
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	203551	ACTAVIS
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	209640	AMNEAL
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	204193	DR REDDYS
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	207252	HENGRUI PHARMA
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	204490	HIKMA
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	205934	SHILPA
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	210327	SHILPA
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	022534	SUN PHARM
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	216677	ACIC PHARMS
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	203551	ACTAVIS
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	209640	AMNEAL
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	204193	DR REDDYS
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	207252	HENGRUI PHARMA
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	204490	HIKMA
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	205934	SHILPA
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	210327	SHILPA
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	022534	SUN PHARM
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
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	HENGRUI PHARMA
DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	208137	MYLAN LABS LTD
DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	205934	SHILPA
DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	210327	SHILPA
DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	022534	SUN PHARM
TAXOTERE	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	020449	SANOFI AVENTIS US

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