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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022534
Company: SUN PHARM

Summary Review

Products on NDA 022534

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOCEFREZ	DOCETAXEL	20MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	Yes	No
DOCEFREZ	DOCETAXEL	80MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	Yes	No
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No
DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022534

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/03/2011	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022534s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022534s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022534s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022534_docefrez_toc.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022534Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/22/2023	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022534s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022534Orig1s017ltr.pdf
12/09/2022	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022534s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022534Orig1s016ltr.pdf
02/01/2021	SUPPL-12	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022534s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022534Orig1s012ltr.pdf
02/25/2020	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022534s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022534Orig1s011ltr.pdf
01/08/2019	SUPPL-7	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022534s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022534Orig1s007ltr.pdf
05/05/2015	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
02/03/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/30/2014	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022534s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022534Orig1s004ltr.pdf
06/21/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/13/2012	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022534s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022534Orig1s002ltr.pdf

Labels for NDA 022534

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/22/2023	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022534s017lbl.pdf
12/09/2022	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022534s016lbl.pdf
02/01/2021	SUPPL-12	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022534s012lbl.pdf
02/01/2021	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022534s012lbl.pdf
02/25/2020	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022534s011lbl.pdf
01/08/2019	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022534s007lbl.pdf
10/30/2014	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022534s004lbl.pdf
07/13/2012	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022534s002lbl.pdf
05/03/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022534s000lbl.pdf

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