Details for New Drug Application (NDA): 215744

NDA 215744 describes DOCETAXEL, which is a drug marketed by Accord Hlthcare, Acic Pharms, Actavis, Alembic, Amneal, Apotex Inc, Dfb Oncology Ltd, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hengrui Pharma, 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-one suppliers are listed for this compound. Additional details are available on the docetaxel profile page.

Summary for 215744

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

Pharmacology for NDA: 215744

Physiological Effect

Microtubule Inhibition

Suppliers and Packaging for NDA: 215744

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOCETAXEL	docetaxel	INJECTABLE;INJECTION	215744	ANDA	Alembic Pharmaceuticals Limited	46708-678	46708-678-02	1 VIAL, SINGLE-DOSE in 1 CARTON (46708-678-02) / 2 mL in 1 VIAL, SINGLE-DOSE
DOCETAXEL	docetaxel	INJECTABLE;INJECTION	215744	ANDA	Alembic Pharmaceuticals Limited	46708-678	46708-678-08	1 VIAL, MULTI-DOSE in 1 CARTON (46708-678-08) / 8 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:	Feb 28, 2023	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	80MG/8ML (10MG/ML)
Approval Date:	Feb 28, 2023	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	160MG/16ML (10MG/ML)
Approval Date:	Feb 28, 2023	TE:	AP	RLD:	No

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