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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020212
Company: PFIZER

Products on NDA 020212

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZINECARD	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No
ZINECARD	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020212

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
05/12/2025	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020212s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020212Orig1s021ltr.pdf
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.

Labels for NDA 020212

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2025	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020212s021lbl.pdf
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

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