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Generated: December 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207326

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NDA 207326 describes PACITAXEL, which is a drug marketed by Gland Pharma Ltd and is included in one NDA. It is available from four suppliers. Additional details are available on the PACITAXEL profile page.

The generic ingredient in PACITAXEL 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 207326
Tradename:PACITAXEL
Applicant:Gland Pharma Ltd
Ingredient:paclitaxel
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207326
Physiological EffectMicrotubule Inhibition
Medical Subject Heading (MeSH) Categories for 207326
Suppliers and Packaging for NDA: 207326
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PACITAXEL paclitaxel INJECTABLE;INJECTION 207326 ANDA Alvogen Inc. 47781-593 47781-593-07 1 VIAL, MULTI-DOSE in 1 CARTON (47781-593-07) > 5 mL in 1 VIAL, MULTI-DOSE
PACITAXEL paclitaxel INJECTABLE;INJECTION 207326 ANDA Alvogen Inc. 47781-594 47781-594-07 1 VIAL, MULTI-DOSE in 1 CARTON (47781-594-07) > 16.7 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML
Approval Date:Aug 23, 2016TE:APRLD:No

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