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Last Updated: December 21, 2024

Details for New Drug Application (NDA): 078167

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NDA 078167 describes PACLITAXEL, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Alembic, Dash Pharms, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, MSN, Norvium Bioscience, Pliva Lachema, Sandoz, Teva Pharms, Teva Pharms Usa, Am Regent, Hengrui Pharma, and Teva Pharms Inc, and is included in nineteen NDAs. It is available from sixteen 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 078167

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

Medical Subject Heading (MeSH) Categories for 078167

Antineoplastic Agents, Phytogenic
Tubulin Modulators

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	6MG/ML
Approval Date:	Dec 26, 2007	TE:		RLD:	No

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