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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203877

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NDA 203877 describes DOCETAXEL, which is a drug marketed by Accord Hlthcare, Actavis Llc, Apotex Inc, Dfb Oncology Ltd, Dr Reddys Labs Ltd, Hospira Inc, Ingenus Pharms Llc, Jiangsu Hengrui Med, Pfizer Labs, Sandoz, Teva Pharms Usa, and Eagle Pharms, and is included in thirteen NDAs. It is available from thirteen suppliers. There are two patents protecting this drug. Additional details are available on the DOCETAXEL profile page.

The generic ingredient in DOCETAXEL is docetaxel. There are forty drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the docetaxel profile page.

Summary for 203877

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 203877

Physiological EffectMicrotubule Inhibition

Suppliers and Packaging for NDA: 203877

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOCETAXEL docetaxel INJECTABLE;INJECTION 203877 ANDA Teva Parenteral Medicines, Inc. 0703-5720 0703-5720-01 1 VIAL, SINGLE-USE in 1 CARTON (0703-5720-01) > 1 mL in 1 VIAL, SINGLE-USE
DOCETAXEL docetaxel INJECTABLE;INJECTION 203877 ANDA Teva Parenteral Medicines, Inc. 0703-5730 0703-5730-01 1 VIAL, SINGLE-USE in 1 CARTON (0703-5730-01) > 4 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML (20MG/ML)
Approval Date:Sep 16, 2015TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/4ML (20MG/ML)
Approval Date:Sep 16, 2015TE:APRLD:No


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