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 | Yes |
| RX/OTC/DISCN: | RX |
| TE Code: | AB |
| Patent and Exclusivity Info for this product: | View |
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| 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 | Yes |
| 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, 2013 |
| Patent and Generic Drug Product Data Last Updated: May 17, 2013 |
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