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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 075278

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NDA 075278 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 075278

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

Medical Subject Heading (MeSH) Categories for 075278

Antineoplastic Agents, Phytogenic
Tubulin Modulators

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	6MG/ML
Approval Date:	Jan 25, 2002	TE:		RLD:	No

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