Details for New Drug Application (NDA): 209659

NDA 209659 describes BORTEZOMIB, which is a drug marketed by Accord Hlthcare, Apotex, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hetero Labs Ltd Vi, Hospira, Jiangsu Hansoh Pharm, Meitheal, MSN, Norvium Bioscience, Pharmascience Inc, Qilu Pharm Hainan, Reliance Life Sci, Sandoz, Scinopharm Taiwan, Teva Pharms Usa, Zydus Pharms, Maia Pharms Inc, and Shilpa, and is included in twenty-five NDAs. It is available from twenty-four suppliers. There are four patents protecting this drug. Additional details are available on the BORTEZOMIB profile page.

The generic ingredient in BORTEZOMIB 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 209659

Tradename:	BORTEZOMIB
Applicant:	Fresenius Kabi Usa
Ingredient:	bortezomib
Patents:	0

Pharmacology for NDA: 209659

Mechanism of Action

Proteasome Inhibitors

Medical Subject Heading (MeSH) Categories for 209659

Antineoplastic Agents

Suppliers and Packaging for NDA: 209659

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BORTEZOMIB	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	209659	ANDA	Fresenius Kabi USA, LLC	63323-821	63323-821-10	1 VIAL, SINGLE-USE in 1 CARTON (63323-821-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS			Strength	3.5MG/VIAL
Approval Date:	May 2, 2022	TE:	AP	RLD:	No

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