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Last Updated: October 14, 2024

Details for New Drug Application (NDA): 207252


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NDA 207252 describes DOCETAXEL, which is a drug marketed by Accord Hlthcare, Acic Pharms, Actavis, Alembic, Amneal, Apotex Inc, Dfb Oncology Ltd, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hengrui Pharma, Hikma, Hospira Inc, Meitheal, Mylan Labs Ltd, Norvium Bioscience, Novast Labs, Pfizer Labs, Sandoz, Shilpa, Sun Pharm, and Teva Pharms Usa, and is included in twenty-seven NDAs. It is available from twenty suppliers. There are four patents protecting this drug. Additional details are available on the DOCETAXEL profile page.

The generic ingredient in DOCETAXEL is docetaxel. There are forty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the docetaxel profile page.
Summary for 207252
Tradename:DOCETAXEL
Applicant:Hengrui Pharma
Ingredient:docetaxel
Patents:0
Pharmacology for NDA: 207252
Physiological EffectMicrotubule Inhibition
Suppliers and Packaging for NDA: 207252
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOCETAXEL docetaxel INJECTABLE;INJECTION 207252 ANDA Sagent Pharmaceuticals 25021-245 25021-245-01 1 VIAL in 1 CARTON (25021-245-01) / 1 mL in 1 VIAL
DOCETAXEL docetaxel INJECTABLE;INJECTION 207252 ANDA Sagent Pharmaceuticals 25021-245 25021-245-04 1 VIAL in 1 CARTON (25021-245-04) / 4 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML (20MG/ML)
Approval Date:Aug 9, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/4ML (20MG/ML)
Approval Date:Aug 9, 2017TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength160MG/8ML (20MG/ML)
Approval Date:Aug 9, 2017TE:APRLD:No

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