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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 213434

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NDA 213434 describes PACLITAXEL, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Alembic, Dash Pharms, Fresenius Kabi Usa, Gland, Hikma, Hospira, MSN, Pharmobedient, Pliva Lachema, Sandoz, Teva Pharms, Teva Pharms Usa, Am Regent, Cipla, Hengrui Pharma, Mylan, Shuangcheng, and Teva Pharms Inc, and is included in twenty-two NDAs. It is available from seventeen suppliers. Additional details are available on the PACLITAXEL profile page.

The generic ingredient in PACLITAXEL 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 213434

Tradename:	PACLITAXEL
Applicant:	Msn
Ingredient:	paclitaxel
Patents:	0

Pharmacology for NDA: 213434

Physiological Effect	Microtubule Inhibition

Medical Subject Heading (MeSH) Categories for 213434

Antineoplastic Agents, Phytogenic
Tubulin Modulators

Suppliers and Packaging for NDA: 213434

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	213434	ANDA	Northstar Rx LLC	16714-137	16714-137-01	1 VIAL, MULTI-DOSE in 1 CARTON (16714-137-01) / 50 mL in 1 VIAL, MULTI-DOSE
PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	213434	ANDA	BluePoint Laboratories	68001-516	68001-516-27	1 VIAL, MULTI-DOSE in 1 CARTON (68001-516-27) / 50 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	6MG/ML
Approval Date:	Aug 24, 2020	TE:	AP	RLD:	No

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