Application 208645

Type: NDA
Sponsor: ACTAVIS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BORTEZOMIB	BORTEZOMIB	INJECTABLE; INJECTION	2.5MG/ML	No	No
002	BORTEZOMIB	BORTEZOMIB	INJECTABLE; INJECTION	3.5MG/1.4ML	No	No

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bortezomib	BORTEZOMIB	Sintetica US LLC	d79a71ec-b46d-4961-ad05-8980915cba94	2023-10-09	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
BORTEZOMIB	BORTEZOMIB	Hospira, Inc.	9fdf6169-699f-40eb-bda1-760253062b3c	2023-02-27	Warnings, Adverse reactions	Name fallback brand name: BORTEZOMIB generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	Novadoz Pharmaceuticals LLC	d41340c2-7fe8-42b2-aaa5-c9f9b0e9b50e	2022-07-20	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	BluePoint Laboratories	12500f21-8e2f-4bcd-861e-4dfca843da2e	2022-05-16	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	Qilu Pharmaceutical Co., Ltd.	aef02171-bf8a-43ad-b40c-7642623f9802	2022-05-09	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
BORTEZOMIB	BORTEZOMIB	Zydus Lifesciences Limited	582c7c0d-fa25-4586-8157-a1e2653d72d9	2022-05-05		Name fallback brand name: BORTEZOMIB generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	Pharmascience Inc.	191d231a-1fbd-4a65-9d33-d5dc03bac381	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	Waverley Pharma Inc	a73d7ea7-d068-4d25-b368-fc3db1898be2	2022-04-13	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB
bortezomib	BORTEZOMIB	Hikma Pharmaceuticals USA Inc.	854be921-5fd9-482a-8432-a0c0241625f8	2021-11-22	Warnings, Adverse reactions	Name fallback brand name: bortezomib generic name: BORTEZOMIB
Bortezomib	BORTEZOMIB	MAIA Pharmaceuticals, Inc.	c40e6a28-d577-43d4-bca6-bef28da1d580	2021-09-22	Warnings, Adverse reactions	Name fallback brand name: Bortezomib generic name: BORTEZOMIB

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45630	ORIG	2016-10-21