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Generated: November 20, 2018

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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 EffectMicrotubule Inhibition
Medical Subject Heading (MeSH) Categories for 020262
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:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 29, 1992TE:APRLD:Yes

Expired US Patents for NDA 020262

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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