Details for New Drug Application (NDA): 021660

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NDA 021660 describes ABRAXANE, which is a drug marketed by Bristol-myers and is included in one NDA. It is available from three suppliers. 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-nine drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.

Summary for 021660

Tradename:	ABRAXANE
Applicant:	Bristol-myers
Ingredient:	paclitaxel
Patents:	11

Pharmacology for NDA: 021660

Physiological Effect	Microtubule Inhibition

Medical Subject Heading (MeSH) Categories for 021660

Antineoplastic Agents, Phytogenic
Tubulin Modulators

Suppliers and Packaging for NDA: 021660

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660	NDA AUTHORIZED GENERIC	TWi Pharmaceuticals, Inc.	24979-710	24979-710-51	1 VIAL, SINGLE-USE in 1 CARTON (24979-710-51) / 20 mL in 1 VIAL, SINGLE-USE
ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660	NDA AUTHORIZED GENERIC	Apotex Corp.	60505-6230	60505-6230-4	1 VIAL, SINGLE-USE in 1 CARTON (60505-6230-4) / 20 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	100MG/VIAL
Approval Date:	Jan 7, 2005	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Aug 21, 2026	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	Patent Expiration:	Apr 27, 2025	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	Patent Expiration:	Jun 9, 2024	Product Flag?		Substance Flag?		Delist Request?

Expired US Patents for NDA 021660

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	⤷ Sign Up	⤷ Sign Up
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	⤷ Sign Up	⤷ Sign Up
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	⤷ Sign Up	⤷ Sign Up
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	⤷ Sign Up	⤷ Sign Up
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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