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CLOLAR از شرکت GENZYME

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CLOLAR از شرکت GENZYME

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) SOLUTION;INTRAVENOUS 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
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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 LABS LTD
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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