Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_Rx" table for query on "050718."



Active Ingredient: DOXORUBICIN HYDROCHLORIDE
Dosage Form;Route: INJECTABLE, LIPOSOMAL;INJECTION
Proprietary Name: DOXIL (LIPOSOMAL)
Applicant: JANSSEN RES AND DEV
Strength: 20MG/10ML (2MG/ML)
Application Number: N050718
Product Number: 001
Approval Date: Nov 17, 1995
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: DOXORUBICIN HYDROCHLORIDE
Dosage Form;Route: INJECTABLE, LIPOSOMAL;INJECTION
Proprietary Name: DOXIL (LIPOSOMAL)
Applicant: JANSSEN RES AND DEV
Strength: 50MG/25ML (2MG/ML)
Application Number: N050718
Product Number: 002
Approval Date: Jun 13, 2000
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through April 01, 2014
Patent and Generic Drug Product Data Last Updated April 23, 2014

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