Details for New Drug Application (NDA): 020449
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NDA 020449 describes TAXOTERE, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. Additional details are available on the TAXOTERE profile page.
The generic ingredient in TAXOTERE is docetaxel. There are forty-one drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the docetaxel profile page.
The generic ingredient in TAXOTERE is docetaxel. There are forty-one drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the docetaxel profile page.
Summary for 020449
| Tradename: | TAXOTERE |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | docetaxel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020449
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TAXOTERE | docetaxel | INJECTABLE;INJECTION | 020449 | NDA AUTHORIZED GENERIC | Sanofi-Aventis U.S. LLC | 0955-1020 | 0955-1020-01 | 1 VIAL, GLASS in 1 CARTON (0955-1020-01) / 1 mL in 1 VIAL, GLASS |
| TAXOTERE | docetaxel | INJECTABLE;INJECTION | 020449 | NDA AUTHORIZED GENERIC | Sanofi-Aventis U.S. LLC | 0955-1021 | 0955-1021-04 | 1 VIAL, GLASS in 1 CARTON (0955-1021-04) / 4 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | May 14, 1996 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML (20MG/ML) | ||||
| Approval Date: | Aug 3, 2010 | TE: | RLD: | Yes | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 80MG/4ML (20MG/ML) | ||||
| Approval Date: | Aug 2, 2010 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020449
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | TAXOTERE | docetaxel | INJECTABLE;INJECTION | 020449-001 | May 14, 1996 | 5,750,561*PED | ⤷ Get Started Free |
| Sanofi Aventis Us | TAXOTERE | docetaxel | INJECTABLE;INJECTION | 020449-004 | Aug 2, 2010 | 5,750,561*PED | ⤷ Get Started Free |
| Sanofi Aventis Us | TAXOTERE | docetaxel | INJECTABLE;INJECTION | 020449-001 | May 14, 1996 | 4,814,470*PED | ⤷ Get Started Free |
| Sanofi Aventis Us | TAXOTERE | docetaxel | INJECTABLE;INJECTION | 020449-001 | May 14, 1996 | 5,714,512*PED | ⤷ Get Started Free |
| Sanofi Aventis Us | TAXOTERE | docetaxel | INJECTABLE;INJECTION | 020449-003 | Aug 3, 2010 | 4,814,470*PED | ⤷ Get Started Free |
| Sanofi Aventis Us | TAXOTERE | docetaxel | INJECTABLE;INJECTION | 020449-001 | May 14, 1996 | 5,438,072*PED | ⤷ Get Started Free |
| Sanofi Aventis Us | TAXOTERE | docetaxel | INJECTABLE;INJECTION | 020449-004 | Aug 2, 2010 | 4,814,470*PED | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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