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Last Updated: April 15, 2026

Details for New Drug Application (NDA): 091540

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NDA 091540 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 eighteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.

Summary for 091540

Tradename:	PACLITAXEL
Applicant:	Dash Pharms
Ingredient:	paclitaxel
Patents:	0

Pharmacology for NDA: 091540

Physiological Effect	Microtubule Inhibition

Medical Subject Heading (MeSH) Categories for 091540

Antineoplastic Agents, Phytogenic
Tubulin Modulators

Suppliers and Packaging for NDA: 091540

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	091540	ANDA	Natco Pharma USA LLC	69339-227	69339-227-05	1 VIAL, MULTI-DOSE in 1 CARTON (69339-227-05) / 5 mL in 1 VIAL, MULTI-DOSE
PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	091540	ANDA	Natco Pharma USA LLC	69339-228	69339-228-17	1 VIAL, MULTI-DOSE in 1 CARTON (69339-228-17) / 16.7 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	6MG/ML
Approval Date:	Sep 29, 2011	TE:		RLD:	No

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