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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 217877

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NDA 217877 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 217877

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

Pharmacology for NDA: 217877

Physiological Effect	Microtubule Inhibition

Medical Subject Heading (MeSH) Categories for 217877

Antineoplastic Agents, Phytogenic
Tubulin Modulators

Suppliers and Packaging for NDA: 217877

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PACLITAXEL	paclitaxel	POWDER;INTRAVENOUS	217877	ANDA	Mylan Institutional LLC	67457-937	67457-937-50	20 mL in 1 VIAL (67457-937-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	100MG/VIAL
Approval Date:	Aug 19, 2025	TE:	AB	RLD:	No

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