Details for New Drug Application (NDA): 202963

NDA 202963 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 202963

Tradename:	BORTEZOMIB
Applicant:	Dr Reddys
Ingredient:	bortezomib
Patents:	0

Pharmacology for NDA: 202963

Mechanism of Action

Proteasome Inhibitors

Medical Subject Heading (MeSH) Categories for 202963

Antineoplastic Agents

Suppliers and Packaging for NDA: 202963

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BORTEZOMIB	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	202963	ANDA	Dr.Reddy's Laboratories, Inc.	43598-426	43598-426-60	1 VIAL, SINGLE-DOSE in 1 CARTON (43598-426-60) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
BORTEZOMIB	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	202963	ANDA	NorthStar RxLLC	72603-270	72603-270-01	1 VIAL, SINGLE-DOSE in 1 CARTON (72603-270-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS			Strength	3.5MG/VIAL
Approval Date:	Jul 26, 2022	TE:	AP	RLD:	No

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