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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 209657

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NDA 209657 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 209657

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

Pharmacology for NDA: 209657

Physiological Effect	Microtubule Inhibition

Medical Subject Heading (MeSH) Categories for 209657

Antineoplastic Agents, Phytogenic
Tubulin Modulators

Suppliers and Packaging for NDA: 209657

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PACLITAXEL	paclitaxel	POWDER;INTRAVENOUS	209657	ANDA	Cipla USA Inc.	69097-398	69097-398-78	1 VIAL, SINGLE-DOSE in 1 CARTON (69097-398-78) / 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	100MG/VIAL
Approval Date:	Apr 10, 2025	TE:	AB	RLD:	No

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