FDA.reportPublic FDA data

Application 208645

Type
NDA
Sponsor
ACTAVIS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BORTEZOMIBBORTEZOMIBINJECTABLE; INJECTION2.5MG/MLNoNo
002BORTEZOMIBBORTEZOMIBINJECTABLE; INJECTION3.5MG/1.4MLNoNo

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 1 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BortezomibBORTEZOMIBAvenacy, LLCdecb5d94-2ea2-48d8-b08b-3196b24c0ed32026-01-09Warnings, Adverse reactionsName fallback
brand name: Bortezomib
generic name: BORTEZOMIB
BortezomibBORTEZOMIBGland Pharma Limitedcd698074-da21-4b53-8f6b-241535a8d5982026-01-08Warnings, Adverse reactionsName fallback
brand name: Bortezomib
generic name: BORTEZOMIB
BortezomibBORTEZOMIBNingbo Shuangcheng Pharmaceutical Co., Ltd.b17ca681-59a5-4af7-98a4-953b383798932025-12-30Warnings, Adverse reactionsName fallback
brand name: Bortezomib
generic name: BORTEZOMIB
BORTEZOMIBBORTEZOMIBEugia US LLCed526447-a4fe-403b-8f08-21ce1b2fa8b72025-12-23Warnings, Adverse reactionsName fallback
brand name: BORTEZOMIB
generic name: BORTEZOMIB
BortezomibBORTEZOMIBBluePoint Laboratories10f60367-0476-4acd-861b-90c18d4b81642025-11-20Warnings, Adverse reactionsName fallback
brand name: Bortezomib
generic name: BORTEZOMIB
BORTEZOMIBBORTEZOMIBApotex Corpb605b541-4bfd-db3e-9710-11c27f6dee6c2025-09-16Warnings, Adverse reactionsName fallback
brand name: BORTEZOMIB
generic name: BORTEZOMIB
VELCADEBORTEZOMIBTakeda Pharmaceuticals America, Inc.1521d321-e724-4ffc-adad-34bf4f44fac72025-08-28Warnings, Adverse reactionsName fallback
generic name: BORTEZOMIB
BortezomibBORTEZOMIBBluePoint Laboratoriesc6b620c6-f3d6-4ff3-b46a-50a66e6d41dd2025-07-31Warnings, Adverse reactionsName fallback
brand name: Bortezomib
generic name: BORTEZOMIB
BortezomibBORTEZOMIBMeitheal Pharmaceuticals Inc.322e315f-dd94-475f-94f4-4d86a7eb55902025-07-23Warnings, Adverse reactionsName fallback
brand name: Bortezomib
generic name: BORTEZOMIB
BORUZUBORTEZOMIBAmneal Pharmaceuticals LLCb92628dd-fa09-4c3a-b6a3-66426025807c2025-07-05Warnings, Adverse reactionsName fallback
generic name: BORTEZOMIB
BortezomibBORTEZOMIBSomerset Therapeutics LLCdc737d3d-2a4e-448a-ad70-e013065c411c2025-05-10Warnings, Adverse reactionsName fallback
brand name: Bortezomib
generic name: BORTEZOMIB
BortezomibBORTEZOMIBNorthStar RxLLC3f02670b-5683-780c-9d38-5d8f0ef43a142025-05-06Warnings, Adverse reactionsName fallback
brand name: Bortezomib
generic name: BORTEZOMIB
BORTEZOMIBBORTEZOMIBSagent Pharmaceuticals945fbaf0-7a79-4676-aa90-e9a213c0654f2025-05-05Warnings, Adverse reactionsName fallback
brand name: BORTEZOMIB
generic name: BORTEZOMIB
BortezomibBORTEZOMIBFresenius Kabi USA, LLC3494c357-a692-4e55-89e1-93532b0baef72025-03-27Warnings, Adverse reactionsName fallback
brand name: Bortezomib
generic name: BORTEZOMIB
BORTEZOMIBBORTEZOMIBZydus Pharmaceuticals USA Inc.0eb8daef-18da-43bb-b7c6-38c4c8b5dd802024-12-05Warnings, Adverse reactionsName fallback
brand name: BORTEZOMIB
generic name: BORTEZOMIB
BortezomibBORTEZOMIBShilpa Medicare Limited61539d49-dc21-4576-8813-4bc8abf3868c2024-08-30Warnings, Adverse reactionsName fallback
brand name: Bortezomib
generic name: BORTEZOMIB
BortezomibBORTEZOMIBCamber Pharmaceuticals, Inc.04aafa6a-a50d-4a47-a831-be8e8bb992ac2024-07-22Warnings, Adverse reactionsName fallback
brand name: Bortezomib
generic name: BORTEZOMIB
BortezomibBORTEZOMIBDr.Reddy's Laboratories, Inc.664bee24-7af2-2099-ac99-5dd71a1e5a142024-05-17Warnings, Adverse reactionsName fallback
brand name: Bortezomib
generic name: BORTEZOMIB
BortezomibBORTEZOMIBHospira, Inc.41e3de39-8278-4a75-badf-601e4602080d2024-04-09Warnings, Adverse reactionsName fallback
brand name: Bortezomib
generic name: BORTEZOMIB
BORTEZOMIBBORTEZOMIBEugia US LLC76c7c3a5-fd2f-403f-85fd-65a64538eee72023-10-20Warnings, Adverse reactionsName fallback
brand name: BORTEZOMIB
generic name: BORTEZOMIB

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45630ORIG2016-10-21