Details for New Drug Application (NDA): 075184

NDA 075184 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 075184

Tradename:	PACLITAXEL
Applicant:	Teva Pharms
Ingredient:	paclitaxel
Patents:	0

Pharmacology for NDA: 075184

Physiological Effect

Microtubule Inhibition

Medical Subject Heading (MeSH) Categories for 075184

Antineoplastic Agents, Phytogenic

Tubulin Modulators

Suppliers and Packaging for NDA: 075184

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	075184	ANDA	Teva Parenteral Medicines, Inc.	0703-3213	0703-3213-01	1 VIAL, MULTI-DOSE in 1 CARTON (0703-3213-01) / 5 mL in 1 VIAL, MULTI-DOSE
PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	075184	ANDA	Teva Parenteral Medicines, Inc.	0703-3213	0703-3213-81	1 VIAL, MULTI-DOSE in 1 CARTON (0703-3213-81) / 5 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

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

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