FDA.reportPublic FDA data

Application 218061

Type
ANDA
Sponsor
XIROMED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETRORELIX ACETATECETRORELIX ACETATEPOWDER;SUBCUTANEOUSEQ 0.25MG BASE/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
A218061-001CETRORELIX ACETATECETRORELIX ACETATEEQ 0.25MG BASE/VIALPOWDER / SUBCUTANEOUSAP2025-06-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A218061-001AP

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
2026-02-19 14:30 UTC2026-02A218061-001CETRORELIX ACETATEEQ 0.25MG BASE/VIALPOWDER / SUBCUTANEOUSAP2025-06-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218061-001CETRORELIX ACETATEEQ 0.25MG BASE/VIALPOWDER / SUBCUTANEOUSAP2025-06-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A218061-001CETRORELIX ACETATEEQ 0.25MG BASE/VIALPOWDER / SUBCUTANEOUSAP2025-06-036a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218061-001CETRORELIX ACETATEEQ 0.25MG BASE/VIALPOWDER / SUBCUTANEOUSAP2025-06-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218061-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218061-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218061-001AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218061-001AP1a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CetrotideCETRORELIX ACETATEEMD Serono, Inc.aca7768e-28a7-4027-b1d8-e66247665f792025-09-22Warnings, Adverse reactionsName fallback
generic name: CETRORELIX ACETATE
Cetrorelix acetateCETRORELIX ACETATE FOR INJECTIONApotex Corp.95b852d6-26a4-4aaf-a4c3-26340a24723d2025-06-12Warnings, Adverse reactionsName fallback
brand name: Cetrorelix acetate
Cetrorelix AcetateCETRORELIX ACETATEMeitheal Pharmaceuticals Inc.9b3057ac-6cac-4509-a355-df76247b992c2024-09-10Warnings, Adverse reactionsName fallback
brand name: Cetrorelix Acetate
generic name: CETRORELIX ACETATE
cetrorelix acetateCETRORELIX ACETATEGland Pharma Limited89f8f8ee-68ac-4ed0-a7e3-ffd6e0c1290a2024-08-08Warnings, Adverse reactionsName fallback
brand name: cetrorelix acetate
generic name: CETRORELIX ACETATE
cetrorelix acetateCETRORELIX ACETATEFRESENIUS KABI USA, LLCc9c50fcb-b28d-4085-9116-b38a21d31b992024-07-12Warnings, Adverse reactionsName fallback
brand name: cetrorelix acetate
generic name: CETRORELIX ACETATE
Cetrorelix acetateCETRORELIX ACETATE FOR INJECTIONQilu Pharmaceutical Co., Ltd.c1f35ca4-3536-44ca-ad0e-02f4840194562024-04-18Warnings, Adverse reactionsName fallback
brand name: Cetrorelix acetate