Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020212
Company: PFIZER
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZINECARD | DEXRAZOXANE HYDROCHLORIDE | EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
ZINECARD | DEXRAZOXANE HYDROCHLORIDE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
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 |