U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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 1MG/ML INJECTABLE;INJECTION 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

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
Back to Top