FDA.reportPublic FDA data

Application 213823

Type
ANDA
Sponsor
BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BORTEZOMIBBORTEZOMIBINJECTABLE;INTRAVENOUS, SUBCUTANEOUS3.5MG/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213823-001BORTEZOMIBBORTEZOMIB3.5MG/VIALINJECTABLE / INTRAVENOUS, SUBCUTANEOUS2022-05-02

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A213823-001BORTEZOMIB3.5MG/VIALINJECTABLE / INTRAVENOUS, SUBCUTANEOUS2022-05-02a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10019-991BORTEZOMIBbortezomibBaxter Healthcare CorporationANDACurrent
10019-991BORTEZOMIBbortezomibBaxter Healthcare CorporationANDACurrent