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Drugs@FDA: FDA-Approved Drugs

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 5MG/5ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 10MG/10ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 20MG/20ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No

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.

IDARUBICIN HYDROCHLORIDE

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

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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