FDA.reportPublic FDA data

Application 088448

Type
ANDA
Sponsor
ABRAXIS PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXAMETHASONEDEXAMETHASONE SODIUM PHOSPHATEINJECTABLE;INJECTIONEQ 4MG PHOSPHATE/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A088448-001DEXAMETHASONEDEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTION1984-01-25

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A088448-001DEXAMETHASONEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTION1984-01-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088448-001DEXAMETHASONEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTION1984-01-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088448-001DEXAMETHASONEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTION1984-01-25cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A088448-001DEXAMETHASONEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTION1984-01-25a50c72e98297…

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 8 · 151 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEREMEDYREPACK INC.11f10a47-1c42-40e4-89d8-bb000fef497c2026-09-09Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE SODIUM PHOSPHATE
DexamethasoneDEXAMETHASONEREMEDYREPACK INC.8c5375a7-7a0d-4af0-8b86-bc87698ac3d12026-09-04Warnings, Adverse reactionsName fallback
brand name: Dexamethasone
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATESportpharm LLC9822a5c3-d3f1-4e0b-9963-32b22740e10e2026-08-31Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone sodium phosphateDEXAMETHASONE SODIUM PHOSPHATEMicro Labs Limitedc6f2563b-5a39-48bf-bcfe-71dd417bd9702026-08-26Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEASCLEMED USA INC.a31b013f-924c-42f8-b8ab-ce60bb8ad7b82026-08-07Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATESagent Pharmaceuticals4680d517-ed5a-4137-819c-122ee962a4642026-08-06Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE SODIUM PHOSPHATE
DexamethasoneDEXAMETHASONESportpharm LLCa37486b9-4323-41fc-ac7e-869d95dc95682026-07-17Warnings, Adverse reactionsName fallback
brand name: Dexamethasone
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATESportpharm LLCa8aee11f-c928-41ef-8df8-e6d8b355536c2026-07-10Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE SODIUM PHOSPHATE
DexamethasoneDEXAMETHASONEREMEDYREPACK INC.f5c9b70b-b835-4f3b-9643-0aec50a0d3f22026-07-07Warnings, Adverse reactionsName fallback
brand name: Dexamethasone
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLCcca2c160-9188-48e8-9505-49a52388dcb72026-06-30Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLC7cbd9005-7df2-47ee-adb3-7244c1c69bc32026-06-30Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE SODIUM PHOSPHATE
DexamethasoneDEXAMETHASONEPangea Pharmaceuticals, LLCa41e6e26-9ebb-4b06-866e-a24af21c644c2026-06-29Warnings, Adverse reactionsName fallback
brand name: Dexamethasone
DexamethasoneDEXAMETHASONEPD-Rx Pharmaceuticals, Inc.89e1d458-7caa-430f-9c54-360889899a732026-06-12Warnings, Adverse reactionsName fallback
brand name: Dexamethasone
DexamethasoneDEXAMETHASONEPD-Rx Pharmaceuticals, Inc.736861fa-1df8-4afd-ba4a-dd7d7bffd8652026-06-12Warnings, Adverse reactionsName fallback
brand name: Dexamethasone
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLC2b626a48-c7aa-4443-9164-a08ff069ccd12026-06-08Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE SODIUM PHOSPHATE
DexamethasoneDEXAMETHASONEPreferred Pharmaceuticals Inc79b65fd4-16a5-42e0-b041-61d7bda0a5ff2026-06-08Warnings, Adverse reactionsName fallback
brand name: Dexamethasone
DexamethasoneDEXAMETHASONEREMEDYREPACK INC.8deaaaf7-3efd-4065-b29f-e5ef038030f82026-06-01Warnings, Adverse reactionsName fallback
brand name: Dexamethasone
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATECardinal Health 107, LLC6d3cbd54-93ef-40fe-b15a-7a4f52dc5f712026-05-29Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE SODIUM PHOSPHATE
DexamethasoneDEXAMETHASONECardinal Health 107, LLCbf8acfdb-8dc8-4a69-90b0-33c680c421d62026-05-15Warnings, Adverse reactionsName fallback
brand name: Dexamethasone
dexamethasoneDEXAMETHASONECardinal Health 107, LLC5622f8d2-1893-441b-8011-fa90c8a63b0b2026-05-05Warnings, Adverse reactionsName fallback
brand name: dexamethasone

Reported adverse events (FAERS/openFDA)#

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