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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 021602


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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 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021602
Mechanism of ActionProteasome Inhibitors
Medical Subject Heading (MeSH) Categories for 021602
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:RXDosage:INJECTABLE;INTRAVENOUS, SUBCUTANEOUSStrength3.5MG/VIAL
Approval Date:May 13, 2003TE:APRLD: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 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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