Details for New Drug Application (NDA): 213768

NDA 213768 describes DOCETAXEL, which is a drug marketed by Accord Hlthcare, Actavis, 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 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-four suppliers are listed for this compound. Additional details are available on the docetaxel profile page.

Summary for 213768

Tradename:	DOCETAXEL
Applicant:	Guangdong Sunho
Ingredient:	docetaxel
Patents:	0

Pharmacology for NDA: 213768

Physiological Effect

Microtubule Inhibition

Suppliers and Packaging for NDA: 213768

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOCETAXEL	docetaxel	INJECTABLE;INJECTION	213768	ANDA	Meitheal Pharmaceuticals Inc.	71288-133	71288-133-01	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-133-01) / 1 mL in 1 VIAL, SINGLE-DOSE
DOCETAXEL	docetaxel	INJECTABLE;INJECTION	213768	ANDA	Meitheal Pharmaceuticals Inc.	71288-152	71288-152-04	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-152-04) / 4 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/ML (20MG/ML)
Approval Date:	May 13, 2025	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	80MG/4ML (20MG/ML)
Approval Date:	May 13, 2025	TE:	AP	RLD:	No

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