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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 201195


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NDA 201195 describes DOCETAXEL, which is a drug marketed by Accord Hlthcare, Actavis, Alembic, Amneal, Apotex Inc, Dfb Oncology Ltd, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hengrui Pharma, Hikma, Hospira Inc, Meitheal, Mylan Labs Ltd, Novast Labs, Pfizer Labs, Sandoz, Shilpa, Sun Pharm, Teva Pharms Usa, and Avyxa Holdings, and is included in twenty-seven NDAs. It is available from twenty suppliers. There are five 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 201195
Tradename:DOCETAXEL
Applicant:Accord Hlthcare
Ingredient:docetaxel
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201195
Physiological EffectMicrotubule Inhibition
Suppliers and Packaging for NDA: 201195
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOCETAXEL docetaxel INJECTABLE;INJECTION 201195 NDA Accord Healthcare Inc. 16729-267 16729-267-63 1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-63) / 1 mL in 1 VIAL, MULTI-DOSE
DOCETAXEL docetaxel INJECTABLE;INJECTION 201195 NDA Accord Healthcare Inc. 16729-267 16729-267-64 1 VIAL, MULTI-DOSE in 1 CARTON (16729-267-64) / 4 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength20MG/0.5ML (40MG/ML)
Approval Date:Jun 8, 2011TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength80MG/2ML (40MG/ML)
Approval Date:Jun 8, 2011TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML (20MG/ML)
Approval Date:Apr 20, 2012TE:APRLD:Yes

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