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Drugs@FDA: FDA-Approved Drugs

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

Summary Review

Products on NDA 022234

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022234

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/08/2011	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/2011/022234s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022234s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022234s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022234_docetaxel_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022234Orig1s000SumR.pdf

Supplements

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022234s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022234Orig1s022ltr.pdf
11/24/2020	SUPPL-18	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022234s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022234Orig1s018ltr.pdf
10/11/2019	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022234s012s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022234Orig1s012, s013, s015ltr.pdf
10/11/2019	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022234s012s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022234Orig1s012, s013, s015ltr.pdf
10/11/2019	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022234s012s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022234Orig1s012, s013, s015ltr.pdf
09/24/2018	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022234s011,202356s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022234Orig1s011,202356Orig1s003ltr.pdf
08/02/2018	SUPPL-10		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022234Orig1s010Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022234Orig1s010Ltr.pdf
09/27/2017	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022234s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022234Orig1s008ltr.pdf
01/25/2017	SUPPL-5	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022234s005lbl.pdf
06/24/2016	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
07/10/2014	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022234s03lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022234Orig1s003ltr.pdf
01/23/2014	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

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-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
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

Therapeutic Equivalents for NDA 022234

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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