Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065036
Company: MEITHEAL

Products on ANDA 065036

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065036

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/01/2002	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65036ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2023	SUPPL-34	Labeling-Package Insert		Label is not available on this site.
01/27/2022	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
04/27/2020	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
04/27/2020	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
11/22/2011	SUPPL-19	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065036

IDARUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION; 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	1MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	050734	PFIZER
IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	065275	HIKMA
IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	065288	HIKMA
IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	065036	MEITHEAL