Details for New Drug Application (NDA): 212782

NDA 212782 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 212782

Tradename:	BORTEZOMIB
Applicant:	Shilpa
Ingredient:	bortezomib
Patents:	0

Pharmacology for NDA: 212782

Mechanism of Action

Proteasome Inhibitors

Medical Subject Heading (MeSH) Categories for 212782

Antineoplastic Agents

Suppliers and Packaging for NDA: 212782

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BORTEZOMIB	bortezomib	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	212782	NDA	Shilpa Medicare Limited	63759-3032	63759-3032-1	1 VIAL, SINGLE-DOSE in 1 CARTON (63759-3032-1) / 1.4 mL in 1 VIAL, SINGLE-DOSE
BORTEZOMIB	bortezomib	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	212782	NDA	Amneal Pharmaceuticals LLC	70121-2484	70121-2484-1	1 VIAL, SINGLE-DOSE in 1 CARTON (70121-2484-1) / 1.4 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS, SUBCUTANEOUS			Strength	3.5MG/1.4ML (2.5MG/ML)
Approval Date:	Aug 26, 2024	TE:		RLD:	Yes

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