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Details for New Drug Application (NDA): 020262
NDA 020262 describes TAXOL, which is a drug marketed by Hq Spclt Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the TAXOL profile page.
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.
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| INJECTABLE;INJECTION | Strength | 6MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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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