Details for New Drug Application (NDA): 210327

NDA 210327 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 210327

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

Pharmacology for NDA: 210327

Physiological Effect

Microtubule Inhibition

Suppliers and Packaging for NDA: 210327

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOCETAXEL	docetaxel	INJECTABLE;INJECTION	210327	ANDA	Armas Pharmaceuticals Inc.	72485-214	72485-214-01	1 VIAL, SINGLE-USE in 1 CARTON (72485-214-01) / 1 mL in 1 VIAL, SINGLE-USE
DOCETAXEL	docetaxel	INJECTABLE;INJECTION	210327	ANDA	Armas Pharmaceuticals Inc.	72485-215	72485-215-04	1 VIAL, SINGLE-USE in 1 CARTON (72485-215-04) / 4 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20MG/ML (20MG/ML)
Approval Date:	May 16, 2019	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 16, 2019	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	160MG/8ML (20MG/ML)
Approval Date:	May 16, 2019	TE:	AP	RLD:	No

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