Details for New Drug Application (NDA): 020262

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NDA 020262 describes TAXOL, which is a drug marketed by Hq Spclt Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the TAXOL profile page.

The generic ingredient in TAXOL is paclitaxel. There are sixty-nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.

Summary for 020262

Tradename:	TAXOL
Applicant:	Hq Spclt Pharma
Ingredient:	paclitaxel
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020262

Physiological Effect	Microtubule Inhibition

Medical Subject Heading (MeSH) Categories for 020262

Antineoplastic Agents, Phytogenic
Tubulin Modulators

Suppliers and Packaging for NDA: 020262

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TAXOL	paclitaxel	INJECTABLE;INJECTION	020262	NDA	WG Critical Care, LLC	44567-504	44567-504-01	1 VIAL, MULTI-DOSE in 1 CARTON (44567-504-01) > 5 mL in 1 VIAL, MULTI-DOSE
TAXOL	paclitaxel	INJECTABLE;INJECTION	020262	NDA	WG Critical Care, LLC	44567-505	44567-505-01	1 VIAL, MULTI-DOSE in 1 CARTON (44567-505-01) > 16.7 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	6MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
Approval Date:	Dec 29, 1992	TE:	AP	RLD:	Yes

Expired US Patents for NDA 020262

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992	➤ Sign Up	➤ Sign Up
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992	➤ Sign Up	➤ Sign Up
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992	➤ Sign Up	➤ Sign Up
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992	➤ Sign Up	➤ Sign Up
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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