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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050661
Company: PFIZER

Products on NDA 050661

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IDAMYCIN	IDARUBICIN HYDROCHLORIDE	10MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
IDAMYCIN	IDARUBICIN HYDROCHLORIDE	5MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
IDAMYCIN	IDARUBICIN HYDROCHLORIDE	20MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050661

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/1990	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/27/2022	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050661s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050661Orig1s017ltr.pdf
02/10/2021	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050661s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050661Orig1s016ltr.pdf
08/02/2019	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050661s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050661Orig1s015ltr.pdf
12/04/2014	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050661s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050661Orig1s014ltr.pdf
04/02/2002	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
11/21/2000	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
04/07/2000	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
10/11/2002	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50661slr008ltr.pdf
09/30/2002	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50661slr007ltr.pdf
04/22/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/11/1997	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/17/1996	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
04/25/1995	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/29/1993	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
01/07/1991	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 050661

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/27/2022	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050661s017lbl.pdf
02/10/2021	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050661s016lbl.pdf
08/02/2019	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050661s015lbl.pdf
12/04/2014	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050661s014lbl.pdf

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