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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205934
Company: SHILPA

Products on NDA 205934

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205934

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2015	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205934s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205934Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205934Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/05/2023	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205934s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205934Orig1s006ltr.pdf
08/04/2021	SUPPL-5	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205934s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205934Orig1s005ltr.pdf
02/19/2020	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205934s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205934Orig1s003ltr.pdf

Labels for NDA 205934

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/05/2023	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205934s006lbl.pdf
07/05/2023	SUPPL-6	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205934s006lbl.pdf
08/04/2021	SUPPL-5	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205934s005lbl.pdf
08/04/2021	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205934s005lbl.pdf
02/19/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205934s003lbl.pdf
12/22/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205934s000lbl.pdf

Therapeutic Equivalents for NDA 205934

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
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	213768	GUANGDONG SUNHO
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	216677	HERITAGE
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

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
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	213768	GUANGDONG SUNHO
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	216677	HERITAGE
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

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	216677	HERITAGE
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
TAXOTERE	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	020449	SANOFI AVENTIS US

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