Details for New Drug Application (NDA): 204490

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NDA 204490 describes DOCETAXEL, which is a drug marketed by Accord Hlthcare, Actavis, Adaptis, Alembic, Amneal, Apotex Inc, Dfb Oncology Ltd, Dr Reddys, Eugia Pharma, Gland, Guangdong Sunho, Hengrui Pharma, Heritage, Hikma, Hospira Inc, Ingenus Pharms Llc, Meitheal, Mylan Labs Ltd, Pfizer Labs, Pharmobedient, Sandoz, Shilpa, Sun Pharm, and Teva Pharms Usa, and is included in twenty-eight NDAs. It is available from nineteen 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 is one drug master file entry for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the docetaxel profile page.

Summary for 204490

Tradename:	DOCETAXEL
Applicant:	Hikma
Ingredient:	docetaxel
Patents:	0

Pharmacology for NDA: 204490

Physiological Effect

Microtubule Inhibition

Suppliers and Packaging for NDA: 204490

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOCETAXEL	docetaxel	INJECTABLE;INJECTION	204490	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9204	0143-9204-01	1 VIAL, GLASS in 1 CARTON (0143-9204-01) / 1 mL in 1 VIAL, GLASS
DOCETAXEL	docetaxel	INJECTABLE;INJECTION	204490	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9205	0143-9205-01	1 VIAL, GLASS in 1 CARTON (0143-9205-01) / 4 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/ML (20MG/ML)
Approval Date:	Jan 14, 2021	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	80MG/4ML (20MG/ML)
Approval Date:	Jan 14, 2021	TE:	AP	RLD:	No

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