Details for New Drug Application (NDA): 050718
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NDA 050718 describes DOXIL (LIPOSOMAL), which is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. It is available from two suppliers. Additional details are available on the DOXIL (LIPOSOMAL) profile page.
The generic ingredient in DOXIL (LIPOSOMAL) is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.
The generic ingredient in DOXIL (LIPOSOMAL) is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.
Summary for 050718
| Tradename: | DOXIL (LIPOSOMAL) |
| Applicant: | Baxter Hlthcare Corp |
| Ingredient: | doxorubicin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 050718
| Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 050718
Suppliers and Packaging for NDA: 050718
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXIL (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 050718 | NDA | Baxter Healthcare Company | 0338-0063 | 0338-0063-01 | 1 VIAL, SINGLE-USE in 1 CARTON (0338-0063-01) / 10 mL in 1 VIAL, SINGLE-USE |
| DOXIL (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 050718 | NDA | Baxter Healthcare Company | 0338-0067 | 0338-0067-01 | 1 VIAL, SINGLE-USE in 1 CARTON (0338-0067-01) / 25 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE, LIPOSOMAL;INJECTION | Strength | 20MG/10ML (2MG/ML) | ||||
| Approval Date: | Nov 17, 1995 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE, LIPOSOMAL;INJECTION | Strength | 50MG/25ML (2MG/ML) | ||||
| Approval Date: | Jun 13, 2000 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 050718
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Baxter Hlthcare Corp | DOXIL (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 050718-001 | Nov 17, 1995 | ⤷ Get Started Free | ⤷ Get Started Free |
| Baxter Hlthcare Corp | DOXIL (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 050718-002 | Jun 13, 2000 | ⤷ Get Started Free | ⤷ Get Started Free |
| Baxter Hlthcare Corp | DOXIL (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 050718-002 | Jun 13, 2000 | ⤷ Get Started Free | ⤷ Get Started Free |
| Baxter Hlthcare Corp | DOXIL (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 050718-001 | Nov 17, 1995 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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