Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065275
Company: WEST-WARD PHARMS INT
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
12/14/2006 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 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English