Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065036
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IDARUBICIN HYDROCHLORIDE PFS 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
05/01/2002 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
11/22/2011 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

IDARUBICIN HYDROCHLORIDE PFS

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 PHARMACIA AND UPJOHN
IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 065440 FRESENIUS KABI USA
IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 200144 MYLAN LABS LTD
IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 065275 WEST-WARD PHARMS INT
IDARUBICIN HYDROCHLORIDE IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 065288 WEST-WARD PHARMS INT
IDARUBICIN HYDROCHLORIDE PFS IDARUBICIN HYDROCHLORIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 065036 TEVA PHARMS USA

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