FDA.reportPublic FDA data

Application 219454

Type
ANDA
Sponsor
TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GANIRELIX ACETATEGANIRELIX ACETATEINJECTABLE;INJECTION250MCG/0.5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A219454-001GANIRELIX ACETATEGANIRELIX ACETATE250MCG/0.5MLINJECTABLE / INJECTION2025-06-27

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
2026-09-14 22:38:342026-08A219454-001GANIRELIX ACETATE250MCG/0.5MLINJECTABLE / INJECTION2025-06-2784e616aacf4f…
2026-08-18 06:07:402026-07A219454-001GANIRELIX ACETATE250MCG/0.5MLINJECTABLE / INJECTION2025-06-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219454-001GANIRELIX ACETATE250MCG/0.5MLINJECTABLE / INJECTIONAP2025-06-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219454-001GANIRELIX ACETATE250MCG/0.5MLINJECTABLE / INJECTIONAP2025-06-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A219454-001GANIRELIX ACETATE250MCG/0.5MLINJECTABLE / INJECTIONAP2025-06-276a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219454-001GANIRELIX ACETATE250MCG/0.5MLINJECTABLE / INJECTION2025-06-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219454-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219454-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219454-001AP16a471c1ec25d…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ganirelix AcetateGANIRELIX ACETATEMullan Pharmaceutical Inc.420ce739-2756-4fb4-8a4e-5fab501ab9732026-05-11Warnings, Adverse reactionsName fallback
brand name: Ganirelix Acetate
generic name: GANIRELIX ACETATE
Ganirelix AcetateGANIRELIX ACETATEXiromed LLC37a8e041-9751-665a-1965-765f7ff219222026-03-18Warnings, Adverse reactionsName fallback
brand name: Ganirelix Acetate
generic name: GANIRELIX ACETATE
Ganirelix AcetateGANIRELIX ACETATEOrganon LLC32fb74ff-993a-49fe-8943-e029372b863e2025-11-13Warnings, Adverse reactionsName fallback
brand name: Ganirelix Acetate
generic name: GANIRELIX ACETATE
Ganirelix AcetateGANIRELIX ACETATELupin Pharmaceuticals, Inc.e50888ef-5e66-4b15-bdc3-2f6794f092462025-09-03Warnings, Adverse reactionsName fallback
brand name: Ganirelix Acetate
generic name: GANIRELIX ACETATE
Ganirelix AcetateGANIRELIX ACETATEQilu Pharmaceutical Co., Ltd.440f6d67-f02e-4407-8830-39c394e25e5d2025-07-15Warnings, Adverse reactionsName fallback
brand name: Ganirelix Acetate
generic name: GANIRELIX ACETATE
Ganirelix AcetateGANIRELIX ACETATEMeitheal Pharmaceuticals Inc.1f067dfb-f9c7-4020-ab7b-da2ba695ab322025-02-20Warnings, Adverse reactionsName fallback
brand name: Ganirelix Acetate
generic name: GANIRELIX ACETATE
FyremadelGANIRELIX ACETATEFerring Pharmaceuticals Inc.5f0908b5-3551-47fd-95f7-3669b0dff7f12025-01-06Warnings, Adverse reactionsName fallback
generic name: GANIRELIX ACETATE
Ganirelix AcetateGANIRELIX ACETATEFresenius Kabi USA, LLCc23ca7b2-7350-4f07-8adf-046bffb478422024-05-22Warnings, Adverse reactionsName fallback
brand name: Ganirelix Acetate
generic name: GANIRELIX ACETATE
GANIRELIX ACETATEGANIRELIX ACETATEGland Pharma Limitedcad7c09c-234b-4e73-b460-a1b1f7adc28d2023-11-29Warnings, Adverse reactionsName fallback
brand name: GANIRELIX ACETATE
generic name: GANIRELIX ACETATE
Ganirelix AcetateGANIRELIX ACETATEAmphastar Pharmaceuticals, Inc.9c286f64-8039-44ec-8fdd-d1a2f52b4c3c2022-04-19Warnings, Adverse reactionsName fallback
brand name: Ganirelix Acetate
generic name: GANIRELIX ACETATE

Reported adverse events (FAERS/openFDA)#

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