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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050734
Company: PFIZER

Products on NDA 050734

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IDAMYCIN PFS	IDARUBICIN HYDROCHLORIDE	5MG/5ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes
IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	10MG/10ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes
IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050734

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/17/1997	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/06/2026	SUPPL-32	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050734Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/050734Orig1s032ltr.pdf
11/06/2023	SUPPL-31	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050734Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050734Orig1s031ltr.pdf
04/27/2022	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050734s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050734Orig1s029ltr.pdf
02/10/2021	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050734s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050734Orig1s027ltr.pdf
08/02/2019	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050734s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050734Orig1s025ltr.pdf
12/04/2014	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050734s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050734Orig1s022ltr.pdf
11/05/2002	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
04/02/2002	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
11/21/2000	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
05/31/2000	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/31/2000	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/07/2000	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/01/2003	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050734s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50734slr005ltr.pdf
08/12/1999	SUPPL-4	Labeling		Label is not available on this site.

Labels for NDA 050734

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/06/2026	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050734Orig1s032lbl.pdf
11/06/2023	SUPPL-31	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050734Orig1s031lbl.pdf
04/27/2022	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050734s029lbl.pdf
02/10/2021	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050734s027lbl.pdf
08/02/2019	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050734s025lbl.pdf
12/04/2014	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050734s022lbl.pdf
05/01/2003	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050734s005lbl.pdf

Therapeutic Equivalents for NDA 050734

IDAMYCIN PFS

SOLUTION;INTRAVENOUS; 5MG/5ML (1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IDAMYCIN PFS	IDARUBICIN HYDROCHLORIDE	5MG/5ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	050734	PFIZER
IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	5MG/5ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	065275	HIKMA
IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	5MG/5ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	065288	HIKMA
IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	5MG/5ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	065036	MEITHEAL

IDARUBICIN HYDROCHLORIDE

SOLUTION;INTRAVENOUS; 10MG/10ML (1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	10MG/10ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	065275	HIKMA
IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	10MG/10ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	065288	HIKMA
IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	10MG/10ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	065036	MEITHEAL
IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	10MG/10ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	050734	PFIZER

SOLUTION;INTRAVENOUS; 20MG/20ML (1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	065275	HIKMA
IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	065288	HIKMA
IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	065036	MEITHEAL
IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	20MG/20ML (1MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	050734	PFIZER

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