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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 076131

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NDA 076131 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 076131

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

Pharmacology for NDA: 076131

Physiological Effect	Microtubule Inhibition

Medical Subject Heading (MeSH) Categories for 076131

Antineoplastic Agents, Phytogenic
Tubulin Modulators

Suppliers and Packaging for NDA: 076131

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	076131	ANDA	Hospira, Inc.	61703-015	61703-015-04	1 VIAL, MULTI-DOSE in 1 CARTON (61703-015-04) / 5 mL in 1 VIAL, MULTI-DOSE
PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	076131	ANDA	Hospira, Inc.	61703-342	61703-342-09	1 VIAL, MULTI-DOSE in 1 CARTON (61703-342-09) / 5 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	6MG/ML
Approval Date:	May 8, 2002	TE:	AP	RLD:	No

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