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Details for New Drug Application (NDA): 021660
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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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