Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 065037

Expand all

IDARUBICIN HYDROCHLORIDE (IDARUBICIN HYDROCHLORIDE)
5MG/VIAL
Marketing Status: Discontinued

Active Ingredient: IDARUBICIN HYDROCHLORIDE
Proprietary Name: IDARUBICIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A065037
Product Number: 003
Approval Date: May 1, 2002
Applicant Holder Full Name: TEVA PARENTERAL MEDICINES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

IDARUBICIN HYDROCHLORIDE (IDARUBICIN HYDROCHLORIDE)
10MG/VIAL
Marketing Status: Discontinued

Active Ingredient: IDARUBICIN HYDROCHLORIDE
Proprietary Name: IDARUBICIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A065037
Product Number: 002
Approval Date: May 1, 2002
Applicant Holder Full Name: TEVA PARENTERAL MEDICINES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

IDARUBICIN HYDROCHLORIDE (IDARUBICIN HYDROCHLORIDE)
20MG/VIAL
Marketing Status: Discontinued

Active Ingredient: IDARUBICIN HYDROCHLORIDE
Proprietary Name: IDARUBICIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A065037
Product Number: 001
Approval Date: May 1, 2002
Applicant Holder Full Name: TEVA PARENTERAL MEDICINES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information