Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020212
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZINECARD DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
ZINECARD DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/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
05/26/1995 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020212Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/06/2016 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/18/2014 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020212s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020212Orig1s017ltr.pdf
10/03/2013 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/11/2013 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/03/2012 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020212s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020212s013ltr.pdf
05/20/2005 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020212s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020212s008ltr.pdf
10/31/2002 SUPPL-6 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20212se7-004,005,006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20212se7-004,005,006ltr.pdf
10/31/2002 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20212se7-004,005,006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20212se7-004,005,006ltr.pdf
10/31/2002 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20212se7-004,005,006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20212se7-004,005,006ltr.pdf
05/08/2001 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/18/2014 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020212s017lbl.pdf
07/03/2012 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020212s013lbl.pdf
05/20/2005 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020212s008lbl.pdf
10/31/2002 SUPPL-6 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20212se7-004,005,006lbl.pdf
10/31/2002 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20212se7-004,005,006lbl.pdf
10/31/2002 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20212se7-004,005,006lbl.pdf

ZINECARD

INJECTABLE;INJECTION; EQ 250MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXRAZOXANE HYDROCHLORIDE DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 200752 MYLAN INSTITUTIONAL
DEXRAZOXANE HYDROCHLORIDE DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 076068 WEST-WARD PHARMS INT
ZINECARD DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 020212 PHARMACIA AND UPJOHN

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXRAZOXANE HYDROCHLORIDE DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207321 GLAND PHARMA LTD
DEXRAZOXANE HYDROCHLORIDE DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 200752 MYLAN INSTITUTIONAL
DEXRAZOXANE HYDROCHLORIDE DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 076068 WEST-WARD PHARMS INT
ZINECARD DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 020212 PHARMACIA AND UPJOHN

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