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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 077413

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NDA 077413 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 077413

Tradename:	PACLITAXEL
Applicant:	Pliva Lachema
Ingredient:	paclitaxel
Patents:	0

Medical Subject Heading (MeSH) Categories for 077413

Antineoplastic Agents, Phytogenic
Tubulin Modulators

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	6MG/ML
Approval Date:	Mar 12, 2008	TE:		RLD:	No

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