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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065288
Company: HIKMA

Products on ANDA 065288

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 065288

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/15/2007	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 065288

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

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