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#

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 1 ยท 17 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
gemcitabineGEMCITABINE HYDROCHLORIDESagent Pharmaceuticals44bcc16c-341d-49e8-a1c6-95d084667aca2024-09-06Warnings, Adverse reactionsName fallback
brand 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