FDA.reportPublic FDA data

Application 090644

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GEMCITABINEGEMCITABINEINJECTABLE; INJECTION2GNoNo

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 1 ยท 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AVGEMSIGEMCITABINEAvyxa Pharma, LLCe11eeff7-bcaf-4bf1-8da8-88138e01af842026-07-27Warnings, Adverse reactionsName fallback
generic name: GEMCITABINE
GemcitabineGEMCITABINEHospira, Inc.dc02a23b-3ff9-4441-aa91-8e9e629a73152026-04-27Warnings, Adverse reactionsName fallback
brand name: Gemcitabine
generic name: GEMCITABINE
GemcitabineGEMCITABINEHospira, Inc.e18ed1cb-7dd0-4001-bfda-17d1f4587fb82026-04-27Warnings, Adverse reactionsName fallback
brand name: Gemcitabine
generic name: GEMCITABINE
GemcitabineGEMCITABINEHikma Pharmaceuticals USA Inc.d80176fe-3e8b-48be-87c2-9c603013b3fa2025-10-24Warnings, Adverse reactionsName fallback
brand name: Gemcitabine
generic name: GEMCITABINE
GemcitabineGEMCITABINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.c0b1b715-9ff8-43ca-9e49-465f1f3800842025-07-23Warnings, Adverse reactionsName fallback
brand name: Gemcitabine
GEMCITABINEGEMCITABINE HYDROCHLORIDENorthStar Rx LLC5af49a48-f1c0-467d-b5da-ac9f1ae8e34c2025-02-03Warnings, Adverse reactionsName fallback
brand name: GEMCITABINE
GemcitabineGEMCITABINESagent Pharmaceuticals22af3507-4b4f-4cad-9d61-89ffc4aabbc72025-02-03Warnings, Adverse reactionsName fallback
brand name: Gemcitabine
generic name: GEMCITABINE
GEMCITABINEGEMCITABINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.a5949d02-29eb-4626-ad35-b7614bb0fa952025-01-29Warnings, Adverse reactionsName fallback
brand name: GEMCITABINE
GemcitabineGEMCITABINE HYDROCHLORIDEMylan Institutional LLC06dd9d40-74fc-4409-93b1-a46be71263312024-11-11Warnings, Adverse reactionsName fallback
brand name: Gemcitabine
GEMCITABINEGEMCITABINEFresenius Kabi USA, LLCc550dd16-a5e8-44be-87f2-210c15bbb5132024-10-14Warnings, Adverse reactionsName fallback
brand name: GEMCITABINE
generic name: GEMCITABINE
gemcitabineGEMCITABINEDr. Reddy's Laboratories Limitedeafcebc8-ddef-bb6b-fd0a-9d8b9962cdc42024-09-09Warnings, Adverse reactionsName fallback
brand name: gemcitabine
generic name: GEMCITABINE
GemcitabineGEMCITABINEHospira, Inc.d16907e7-a8c8-4039-ace4-cf4e24ba68c02024-08-16Warnings, Adverse reactionsName fallback
brand name: Gemcitabine
generic name: GEMCITABINE
GEMCITABINEGEMCITABINEHospira, Inc.a625c92b-c569-4b98-8d2e-2b3f5e12b34f2024-08-16Warnings, Adverse reactionsName fallback
brand name: GEMCITABINE
generic name: GEMCITABINE
GemcitabineGEMCITABINE HYDROCHLORIDEMeitheal Pharmaceuticals Inc.73ae04d8-38f9-4d3d-b0c2-71d22af1fc862024-08-05Warnings, Adverse reactionsName fallback
brand name: Gemcitabine
GEMCITABINEGEMCITABINEBluePoint Laboratories4031017d-d768-46de-8081-476bcb883f5e2023-09-11Warnings, Adverse reactionsName fallback
brand name: GEMCITABINE
generic name: GEMCITABINE
GEMCITABINEGEMCITABINEFresenius Kabi USA, LLCd1f3951c-d13f-4662-ad4b-ecfc07f591042021-01-20Warnings, Adverse reactionsName fallback
brand name: GEMCITABINE
generic name: GEMCITABINE

Reported adverse events (FAERS/openFDA)#

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