Details for New Drug Application (NDA): 077574

NDA 077574 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 077574

Tradename:	PACLITAXEL
Applicant:	Fresenius Kabi Usa
Ingredient:	paclitaxel
Patents:	0

Pharmacology for NDA: 077574

Physiological Effect

Microtubule Inhibition

Medical Subject Heading (MeSH) Categories for 077574

Antineoplastic Agents, Phytogenic

Tubulin Modulators

Suppliers and Packaging for NDA: 077574

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	077574	ANDA	Fresenius Kabi USA, LLC	63323-763	63323-763-16	1 VIAL, MULTI-DOSE in 1 CARTON (63323-763-16) / 16.7 mL in 1 VIAL, MULTI-DOSE
PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	077574	ANDA	Fresenius Kabi USA, LLC	63323-763	63323-763-50	1 VIAL, MULTI-DOSE in 1 CARTON (63323-763-50) / 50 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	6MG/ML
Approval Date:	Nov 27, 2006	TE:	AP	RLD:	No

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