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Details for New Drug Application (NDA): 020262
The generic ingredient in TAXOL is paclitaxel. There are sixty-nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.
Summary for 020262
Tradename: | TAXOL |
Applicant: | Hq Spclt Pharma |
Ingredient: | paclitaxel |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020262
Physiological Effect | Microtubule Inhibition |
Medical Subject Heading (MeSH) Categories for 020262
Suppliers and Packaging for NDA: 020262
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TAXOL | paclitaxel | INJECTABLE;INJECTION | 020262 | NDA | WG Critical Care, LLC | 44567-504 | 44567-504-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (44567-504-01) > 5 mL in 1 VIAL, MULTI-DOSE |
TAXOL | paclitaxel | INJECTABLE;INJECTION | 020262 | NDA | WG Critical Care, LLC | 44567-505 | 44567-505-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (44567-505-01) > 16.7 mL in 1 VIAL, MULTI-DOSE |
Paragraph IV (Patent) Challenges for 020262
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
TAXOL | INJECTABLE;INJECTION | paclitaxel | 020262 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 6MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
Approval Date: | Dec 29, 1992 | TE: | RLD: | Yes |
Expired US Patents for NDA 020262
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Hq Spclt Pharma | TAXOL | paclitaxel | INJECTABLE;INJECTION | 020262-001 | Dec 29, 1992 | Start Trial | Start Trial |
Hq Spclt Pharma | TAXOL | paclitaxel | INJECTABLE;INJECTION | 020262-001 | Dec 29, 1992 | Start Trial | Start Trial |
Hq Spclt Pharma | TAXOL | paclitaxel | INJECTABLE;INJECTION | 020262-001 | Dec 29, 1992 | Start Trial | Start Trial |
Hq Spclt Pharma | TAXOL | paclitaxel | INJECTABLE;INJECTION | 020262-001 | Dec 29, 1992 | Start Trial | Start Trial |
Hq Spclt Pharma | TAXOL | paclitaxel | INJECTABLE;INJECTION | 020262-001 | Dec 29, 1992 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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