Details for New Drug Application (NDA): 021602

NDA 021602 describes VELCADE, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. Additional details are available on the VELCADE profile page.

The generic ingredient in VELCADE is bortezomib. There are twenty drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the bortezomib profile page.

Summary for 021602

Tradename:	VELCADE
Applicant:	Takeda Pharms Usa
Ingredient:	bortezomib
Patents:	0

Pharmacology for NDA: 021602

Mechanism of Action

Proteasome Inhibitors

Medical Subject Heading (MeSH) Categories for 021602

Antineoplastic Agents

Suppliers and Packaging for NDA: 021602

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602	NDA	Takeda Pharmaceuticals America, Inc.	63020-049	63020-049-01	1 VIAL in 1 CARTON (63020-049-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS			Strength	3.5MG/VIAL
Approval Date:	May 13, 2003	TE:	AP	RLD:	Yes

Expired US Patents for NDA 021602

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003
Takeda Pharms Usa	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003
Takeda Pharms Usa	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003
Takeda Pharms Usa	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003
Takeda Pharms Usa	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003
Takeda Pharms Usa	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003

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