Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022234
Company: HOSPIRA INC

• Summary Review

Products on NDA 22234

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOCETAXEL	DOCETAXEL	20MG/2ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
DOCETAXEL	DOCETAXEL	80MG/8ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
DOCETAXEL	DOCETAXEL	160MG/16ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes
DOCETAXEL	DOCETAXEL	20MG/ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	None	Yes	No
DOCETAXEL	DOCETAXEL	80MG/4ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	None	Yes	No
DOCETAXEL	DOCETAXEL	120MG/6ML (20MG/ML)	INJECTABLE;INJECTION	Discontinued	None	Yes	No
DOCETAXEL	DOCETAXEL	160MG/8ML (20MG/ML)	INJECTABLE;INJECTION	Prescription	None	Yes	No

Labels for NDA 022234

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/15/2023	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022234s022lbl.pdf
11/24/2020	SUPPL-18	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022234s018lbl.pdf
10/11/2019	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022234s012s013s015lbl.pdf
10/11/2019	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022234s012s013s015lbl.pdf
10/11/2019	SUPPL-12	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022234s012s013s015lbl.pdf
10/11/2019	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022234s012s013s015lbl.pdf
09/24/2018	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022234s011,202356s003lbl.pdf
08/02/2018	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022234Orig1s010Lbl.pdf
09/27/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022234s008lbl.pdf
09/27/2017	SUPPL-8	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022234s008lbl.pdf
01/25/2017	SUPPL-5	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022234s005lbl.pdf
07/10/2014	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022234s03lbl.pdf
03/08/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022234s000lbl.pdf