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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021673
Company: GENZYME

Products on NDA 021673

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOLAR	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021673

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/28/2004	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021673lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021673ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-673_Clolar.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2022	SUPPL-27	Efficacy-Accelerated Approval	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021673s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021673Orig1s027ltr.pdf
12/20/2019	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021673s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021673Orig1s026ltr.pdf
10/27/2016	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021673s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021673Orig1s025ltr.pdf
12/16/2015	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021673s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021673Orig1s024ltr.pdf
09/15/2014	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021673s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021673Orig1s023ltr.pdf
01/10/2013	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021673s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021673Orig1s022ltr.pdf
06/10/2011	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021673s010lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021673s010ltr.pdf
10/17/2008	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021673s005,s007ltr.pdf
10/17/2008	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021673s005,s007ltr.pdf

Labels for NDA 021673

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2022	SUPPL-27	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021673s027lbl.pdf
12/20/2019	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021673s026lbl.pdf
10/27/2016	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021673s025lbl.pdf
12/16/2015	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021673s024lbl.pdf
09/15/2014	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021673s023lbl.pdf
01/10/2013	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021673s022lbl.pdf
06/10/2011	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021673s010lbledt.pdf
12/28/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021673lbl.pdf

Therapeutic Equivalents for NDA 021673

CLOLAR

SOLUTION;INTRAVENOUS; 20MG/20ML (1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	204029	ABON PHARMS LLC
CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212034	ACCORD HLTHCARE
CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	208857	AMNEAL
CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	205375	DR REDDYS
CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	207831	GLAND PHARMA LTD
CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	213461	MEITHEAL
CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	209775	MSN
CLOFARABINE	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	208860	MYLAN LABS LTD
CLOLAR	CLOFARABINE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	021673	GENZYME

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