Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021673
Company: GENZYME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOLAR CLOFARABINE 20MG/20ML (1MG/ML) INJECTABLE;IV (INFUSION) Prescription AP Yes Yes
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

CLOLAR

INJECTABLE;IV (INFUSION); 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) INJECTABLE;IV (INFUSION) Prescription No AP 204029 ABON PHARMS LLC
CLOFARABINE CLOFARABINE 20MG/20ML (1MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 208857 AMNEAL PHARMS CO
CLOFARABINE CLOFARABINE 20MG/20ML (1MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 205375 DR REDDYS LABS LTD
CLOFARABINE CLOFARABINE 20MG/20ML (1MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 208860 MYLAN LABS LTD
CLOLAR CLOFARABINE 20MG/20ML (1MG/ML) INJECTABLE;IV (INFUSION) Prescription Yes AP 021673 GENZYME

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