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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201525
Company: SANDOZ

Summary Review

Products on NDA 201525

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOCETAXEL	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201525

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2011	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/2011/201525s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201525s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201525_docetaxel_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201525Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/21/2023	SUPPL-24	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201525s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/201525Orig1s024ltr.pdf
01/13/2021	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201525s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201525Orig1s022ltr.pdf
08/11/2020	SUPPL-20	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201525s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/201525Orig1s020ltr.pdf
01/06/2020	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201525s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/201525Orig1s019ltr.pdf
03/27/2019	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201525s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201525Orig1s016, 201525Orig1s017ltr.pdf
03/27/2019	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201525s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201525Orig1s016, 201525Orig1s017ltr.pdf
10/21/2016	SUPPL-12	Labeling-Package Insert	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201525Orig1s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/201525Orig1s012.pdf
07/25/2016	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
11/04/2014	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201525Orig1s008,s009ltr.pdf
11/04/2014	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201525Orig1s008,s009ltr.pdf
08/18/2014	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/23/2014	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201525Orig1s003ltr.pdf
03/15/2012	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201525s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201525s002ltr.pdf

Labels for NDA 201525

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/21/2023	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201525s024lbl.pdf
09/21/2023	SUPPL-24	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201525s024lbl.pdf
01/13/2021	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201525s022lbl.pdf
08/11/2020	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201525s020lbl.pdf
08/11/2020	SUPPL-20	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201525s020lbl.pdf
01/06/2020	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201525s019lbl.pdf
03/27/2019	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201525s016s017lbl.pdf
03/27/2019	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201525s016s017lbl.pdf
11/04/2014	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s008s009lbl.pdf
11/04/2014	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s008s009lbl.pdf
04/23/2014	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201525s003lbl.pdf
03/15/2012	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201525s002lbl.pdf
06/29/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201525s000lbl.pdf

Therapeutic Equivalents for NDA 201525

DOCETAXEL

INJECTABLE;INJECTION; 20MG/2ML (10MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOCETAXEL	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	215744	ALEMBIC
DOCETAXEL	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	214575	EUGIA PHARMA
DOCETAXEL	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	213510	GLAND PHARMA LTD
DOCETAXEL	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	022234	HOSPIRA INC
DOCETAXEL	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	209634	MEITHEAL
DOCETAXEL	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	210072	MYLAN LABS LTD
DOCETAXEL	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	201525	SANDOZ

INJECTABLE;INJECTION; 80MG/8ML (10MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	215744	ALEMBIC
DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	214575	EUGIA PHARMA
DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	213510	GLAND PHARMA LTD
DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	022234	HOSPIRA INC
DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	209634	MEITHEAL
DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	210848	MYLAN LABS LTD
DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	207563	NOVAST LABS
DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	201525	SANDOZ

INJECTABLE;INJECTION; 160MG/16ML (10MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	215744	ALEMBIC
DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	214575	EUGIA PHARMA
DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	213510	GLAND PHARMA LTD
DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	022234	HOSPIRA INC
DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	209634	MEITHEAL
DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	208859	MYLAN LABS LTD
DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	207563	NOVAST LABS
DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	201525	SANDOZ

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