FDA.reportPublic FDA data

Application 081125

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

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

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
A081125-001DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTION1990-08-31

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
2026-08-01 22:54:322026-06A081125-001DEXAMETHASONE SODIUM PHOSPHATEEQ 4MG PHOSPHATE/MLINJECTABLE / INJECTION1990-08-31a50c72e98297…

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 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATESportpharm LLCa8aee11f-c928-41ef-8df8-e6d8b355536c2026-07-10Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLCcca2c160-9188-48e8-9505-49a52388dcb72026-06-30Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLC7cbd9005-7df2-47ee-adb3-7244c1c69bc32026-06-30Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLC2b626a48-c7aa-4443-9164-a08ff069ccd12026-06-08Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATECardinal Health 107, LLC6d3cbd54-93ef-40fe-b15a-7a4f52dc5f712026-05-29Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATESportpharm LLC6c7ff5f7-5688-4fc4-9194-9e6b8e6fab592026-04-24Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATECardinal Health 107, LLC7a7ee007-cd02-4f3f-8f0f-82c4964da6e62026-04-21Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEREMEDYREPACK INC.1596a3b4-8c2c-41b4-b1eb-af09863eaa132026-04-15Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirst946f3c1d-0362-d602-e053-2995a90a3d9a2026-03-23Warnings, Adverse reactionsName fallback
brand name: DEXAMETHASONE SODIUM PHOSPHATE
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATESportpharm LLC56bdd2f3-ae94-4fd9-9d05-5b53263a09c12026-03-20Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEREMEDYREPACK INC.6ea9e6ab-0d33-4635-9e98-aa2fbd8921cc2026-03-16Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEA-S Medication Solutionsfe464a39-7820-435c-9385-a4a96d8a38c82026-02-24Warnings, Adverse reactionsName fallback
brand name: DEXAMETHASONE SODIUM PHOSPHATE
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEA-S Medication Solutions0e4f0f22-e6a1-4725-addb-0cc91bed07e92026-02-02Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEHikma Pharmaceuticals USA Inc.0277cc0a-2fd4-4605-a310-b613be84ee262026-01-22Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEHenry Schein, Inc.c464ffde-f64e-4716-92d2-720a107932482026-01-02Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEHenry Schein, Inc.6ded4eac-3f86-4cf8-a05f-3e9c52984d6c2026-01-02Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLCce25183b-cd67-4997-8de9-df59b750883b2025-12-24Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEProPharma Distribution384206f5-75ed-9bd2-e063-6294a90a50382025-12-18Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEProPharma Distribution42c879cc-38dc-c9bc-e063-6294a90a204d2025-12-18Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEFresenius Kabi USA, LLC4dd55929-fe0a-4884-ae0d-6f9435920eb72025-12-17Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE