Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050661

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

Active Ingredient: IDARUBICIN HYDROCHLORIDE
Proprietary Name: IDAMYCIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N050661
Product Number: 002
Approval Date: Sep 27, 1990
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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

Active Ingredient: IDARUBICIN HYDROCHLORIDE
Proprietary Name: IDAMYCIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N050661
Product Number: 001
Approval Date: Sep 27, 1990
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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

Active Ingredient: IDARUBICIN HYDROCHLORIDE
Proprietary Name: IDAMYCIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N050661
Product Number: 003
Approval Date: Apr 25, 1995
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information