Application 065036

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IDARUBICIN HYDROCHLORIDE PFS	IDARUBICIN HYDROCHLORIDE	INJECTABLE;INJECTION	1MG/ML	No	No
002	IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	SOLUTION;INTRAVENOUS	10MG/10ML (1MG/ML)	No	No
003	IDARUBICIN HYDROCHLORIDE	IDARUBICIN HYDROCHLORIDE	SOLUTION;INTRAVENOUS	20MG/20ML (1MG/ML)	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0703-4154	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4154	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4154	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4154	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4154	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4155	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4155	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4155	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4155	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4155	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4156	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4156	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4156	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4156	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-4156	Idarubicin Hydrochloride	Idarubicin Hydrochloride	Teva Parenteral Medicines, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8377	ORIG	2003-04-09