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Last Updated: March 19, 2024

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. Eighteen 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021660
Physiological EffectMicrotubule 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 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:RXDosage:POWDER;INTRAVENOUSStrength100MG/VIAL
Approval Date:Jan 7, 2005TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Aug 21, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try a TrialPatent Expiration:Apr 27, 2025Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try a TrialPatent Expiration:Jun 9, 2024Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 021660

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

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