Details for New Drug Application (NDA): 209634

NDA 209634 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, Heritage, 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-three suppliers are listed for this compound. Additional details are available on the docetaxel profile page.

Summary for 209634

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

Pharmacology for NDA: 209634

Physiological Effect

Microtubule Inhibition

Suppliers and Packaging for NDA: 209634

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOCETAXEL	docetaxel	INJECTABLE;INJECTION	209634	ANDA	Meitheal Pharmaceuticals Inc	71288-144	71288-144-08	1 VIAL, MULTI-DOSE in 1 CARTON (71288-144-08) / 8 mL in 1 VIAL, MULTI-DOSE
DOCETAXEL	docetaxel	INJECTABLE;INJECTION	209634	ANDA	Meitheal Pharmaceuticals Inc	71288-144	71288-144-16	1 VIAL, MULTI-DOSE in 1 CARTON (71288-144-16) / 16 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/2ML (10MG/ML)
Approval Date:	Aug 24, 2018	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	80MG/8ML (10MG/ML)
Approval Date:	Aug 24, 2018	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	160MG/16ML (10MG/ML)
Approval Date:	Aug 24, 2018	TE:	AP	RLD:	No

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