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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 eleven 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-seven 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 NDA: 021660

Tradename:
ABRAXANE
Applicant:
Abraxis Bioscience
Ingredient:
paclitaxel
Patents:11
Formulation / Manufacturing:see details

Pharmacology for NDA: 021660

Physiological EffectMicrotubule Inhibition

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;IV (INFUSION)Strength100MG/VIAL
Approval Date:Jan 7, 2005TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 11, 2015
Regulatory Exclusivity Use:FIRST-LINE TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER, IN COMBINATION WITH CARBOPLATIN, IN PATIENTS WHO ARE NOT CANDIDATES FOR CURATIVE SURGERY OR RADIATION THERAPY
Regulatory Exclusivity Expiration:Sep 6, 2016
Regulatory Exclusivity Use:FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC ADENOCARACINOMA OF THE PANCREAS, IN COMBINATION WITH GEMCITABINE
Regulatory Exclusivity Expiration:Sep 6, 2020
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

Expired Orange Book Patents for NDA: 021660

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 20055,439,686► subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 20056,537,579► subscribe
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 20056,753,006► subscribe
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