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Details for New Drug Application (NDA): 021660
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NDA 021660 describes ABRAXANE, which is a drug marketed by Abraxis Bioscience and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ABRAXANE profile page.
The generic ingredient in ABRAXANE is paclitaxel. There are sixty-nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.
The generic ingredient in ABRAXANE is paclitaxel. There are sixty-nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.
Summary for 021660
| Tradename: | ABRAXANE |
| Applicant: | Abraxis Bioscience |
| Ingredient: | paclitaxel |
| Patents: | 12 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021660
| Physiological Effect | Microtubule Inhibition |
Medical Subject Heading (MeSH) Categories for 021660
Suppliers and Packaging for NDA: 021660
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660 | NDA | Abraxis BioScience, LLC | 68817-134 | 68817-134-50 | 1 VIAL, SINGLE-USE in 1 CARTON (68817-134-50) > 20 mL in 1 VIAL, SINGLE-USE |
Paragraph IV (Patent) Challenges for 021660
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ABRAXANE | FOR SUSPENSION;IV (INFUSION) | paclitaxel | 021660 | 2015-12-11 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;IV (INFUSION) | Strength | 100MG/VIAL | ||||
| Approval Date: | Jan 7, 2005 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 6, 2022 | ||||||||
| Regulatory Exclusivity Use: | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | ||||||||
| Regulatory Exclusivity Expiration: | Jun 6, 2023 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Mar 6, 2021 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
Expired US Patents for NDA 021660
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | Start Trial | Start Trial |
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | Start Trial | Start Trial |
| Abraxis Bioscience | ABRAXANE | paclitaxel | FOR SUSPENSION;IV (INFUSION) | 021660-001 | Jan 7, 2005 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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