Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050682
Company: RECORDATI RARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COSMEGEN DACTINOMYCIN 0.5MG/VIAL INJECTABLE;INJECTION 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
12/10/1964 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/15/2018 SUPPL-34 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050682s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050682Orig1s034ltr.pdf
08/15/2018 SUPPL-33 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050682s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050682Orig1s033ltr.pdf
04/07/2015 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

02/03/2012 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050682s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050682s029,s030ltr.pdf
02/03/2012 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050682s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050682s029,s030ltr.pdf
03/13/2009 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050682s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050682s025ltr.pdf
08/17/2005 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050682s022ltr.pdf
11/30/2004 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50682s021ltr.pdf
03/19/2003 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50682slr020ltr.pdf
10/28/2002 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50682slr019ltr.pdf
02/14/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/2001 SUPPL-17 Labeling

Label is not available on this site.

02/08/1999 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1998 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/07/2000 SUPPL-13 Labeling

Label is not available on this site.

06/06/1997 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/18/1997 SUPPL-10 Labeling

Label is not available on this site.

02/17/1997 SUPPL-9 Labeling

Label is not available on this site.

03/22/1988 SUPPL-7 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/15/2018 SUPPL-34 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050682s034lbl.pdf
08/15/2018 SUPPL-33 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050682s033lbl.pdf
02/03/2012 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050682s029s030lbl.pdf
02/03/2012 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050682s029s030lbl.pdf
03/13/2009 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050682s025lbl.pdf

COSMEGEN

INJECTABLE;INJECTION; 0.5MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COSMEGEN DACTINOMYCIN 0.5MG/VIAL INJECTABLE;INJECTION Prescription Yes AP 050682 RECORDATI RARE
DACTINOMYCIN DACTINOMYCIN 0.5MG/VIAL INJECTABLE;INJECTION Prescription No AP 207232 HISUN PHARM HANGZHOU
DACTINOMYCIN DACTINOMYCIN 0.5MG/VIAL INJECTABLE;INJECTION Prescription No AP 203385 MYLAN LABS LTD
DACTINOMYCIN DACTINOMYCIN 0.5MG/VIAL INJECTABLE;INJECTION Prescription No AP 203999 X-GEN PHARMS INC

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