FDA.reportPublic FDA data

Application 207069

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZTREONAMAZTREONAMINJECTABLE;INJECTION1GM/VIALNoNo
002AZTREONAMAZTREONAMINJECTABLE;INJECTION2GM/VIALNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207069-001AZTREONAMAZTREONAM1GM/VIALINJECTABLE / INJECTION2026-02-05
A207069-002AZTREONAMAZTREONAM2GM/VIALINJECTABLE / INJECTION2026-02-05

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 22:38:342026-08A207069-001AZTREONAM1GM/VIALINJECTABLE / INJECTION2026-02-0584e616aacf4f…
2026-09-14 22:38:342026-08A207069-002AZTREONAM2GM/VIALINJECTABLE / INJECTION2026-02-0584e616aacf4f…
2026-08-18 06:07:402026-07A207069-001AZTREONAM1GM/VIALINJECTABLE / INJECTION2026-02-05caaa826d4ba7…
2026-08-18 06:07:402026-07A207069-002AZTREONAM2GM/VIALINJECTABLE / INJECTION2026-02-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207069-001AZTREONAM1GM/VIALINJECTABLE / INJECTIONAP2026-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207069-002AZTREONAM2GM/VIALINJECTABLE / INJECTIONAP2026-02-05011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207069-001AZTREONAM1GM/VIALINJECTABLE / INJECTION2026-02-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207069-002AZTREONAM2GM/VIALINJECTABLE / INJECTION2026-02-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207069-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207069-002AP1011fe1cb6892…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AZACTAMAZTREONAME.R. Squibb & Sons, L.L.C.9a105eaf-ee77-4016-beeb-d425a5565db22025-12-15Warnings, Adverse reactionsName fallback
generic name: AZTREONAM
CaystonAZTREONAMGilead Sciences, Inc.67300ca3-8c53-4ce4-8e86-2c03be1f9b8a2025-12-01Warnings, Adverse reactionsName fallback
generic name: AZTREONAM
AZACTAMAZTREONAMA-S Medication Solutionsf9d5515e-54bc-4efc-9f49-8ee3e88c3e012025-01-09Warnings, Adverse reactionsName fallback
generic name: AZTREONAM
AztreonamAZTREONAMHospira, Inc.d4500795-3b07-4a7d-b432-73cafbb3dbc62024-06-03Warnings, Adverse reactionsName fallback
brand name: Aztreonam
generic name: AZTREONAM
AztreonamAZTREONAMFresenius Kabi USA, LLC5f5ebb63-6ac5-4fb4-bcc1-d069c123eb182022-05-06Warnings, Adverse reactionsName fallback
brand name: Aztreonam
generic name: AZTREONAM
AztreonamAZTREONAMFresenius Kabi USA, LLC302fd27d-0a22-44ea-91fb-1b1ffcf17a1f2022-04-30Warnings, Adverse reactionsName fallback
brand name: Aztreonam
generic name: AZTREONAM
AztreonamAZTREONAMFresenius Kabi USA, LLCc6cf7e13-a04e-47e2-9cec-44a278ee6bec2022-03-29Warnings, Adverse reactionsName fallback
brand name: Aztreonam
generic name: AZTREONAM

Reported adverse events (FAERS/openFDA)#

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