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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201195
Company: ACCORD HLTHCARE

Summary Review

Products on NDA 201195

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201195

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
09/20/2023	SUPPL-19	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201195s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/201195Orig1s019ltr.pdf
07/20/2020	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201195s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/201195Orig1s015ltr.pdf
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-Container/Carton Labels, Labeling-Package Insert	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

Labels for NDA 201195

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/20/2023	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201195s019lbl.pdf
09/20/2023	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201195s019lbl.pdf
09/20/2023	SUPPL-19	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201195s019lbl.pdf
07/20/2020	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201195s015lbl.pdf
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-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201195s006lbl.pdf
07/03/2014	SUPPL-6	Labeling-Package Insert	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

Therapeutic Equivalents for NDA 201195

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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