Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050467

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

Active Ingredient: DOXORUBICIN HYDROCHLORIDE
Proprietary Name: DOXORUBICIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N050467
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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

Active Ingredient: DOXORUBICIN HYDROCHLORIDE
Proprietary Name: DOXORUBICIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N050467
Product Number: 003
Approval Date: May 20, 1985
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN HYDROCHLORIDE)
50MG/VIAL
Marketing Status: Discontinued

Active Ingredient: DOXORUBICIN HYDROCHLORIDE
Proprietary Name: DOXORUBICIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 50MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N050467
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN HYDROCHLORIDE)
150MG/VIAL
Marketing Status: Discontinued

Active Ingredient: DOXORUBICIN HYDROCHLORIDE
Proprietary Name: DOXORUBICIN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 150MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N050467
Product Number: 004
Approval Date: Jul 22, 1987
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information