Application 089372

Type
ANDA
Sponsor
QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEInjectable; InjectionEQ 24MG PHOSPHATE/MLNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 4 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC8969803e-2e45-1f28-e053-2995a90a05a72023-05-15Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLCbbf0f0ee-1891-4f3d-e053-2a95a90a5e182023-05-04Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC9f69846e-5897-c301-e053-2a95a90a44f12023-05-03Warnings, Adverse reactionsName fallback
brand name: DEXAMETHASONE SODIUM PHOSPHATE
generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLC667323ea-5a5e-3465-e053-2a91aa0a16672023-04-26Warnings, Adverse reactionsName fallback
brand name: DEXAMETHASONE SODIUM PHOSPHATE
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEAsclemed USA, Inc.2d96d5e8-00bf-406b-b345-f1c31865fe942023-04-04Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirst94cb045b-5801-db32-e053-2a95a90a93ef2022-12-10Warnings, Adverse reactionsName fallback
brand name: DEXAMETHASONE SODIUM PHOSPHATE
generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEAsclemed USA, Inc.ca762fbf-6bf5-4b39-8f40-3fb5f1f777782022-10-12Warnings, Adverse reactionsName fallback
brand name: DEXAMETHASONE SODIUM PHOSPHATE
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEBausch & Lomb Incorporated6bdcefbe-51e3-4ca4-afda-5aeca7b6fa732022-08-31Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEAsclemed USA, Inc.b2ce414a-3b1f-4533-bb3a-18594529dead2020-11-25Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE
DMT SUIKDEXAMETHASONE SODIUM PHOSPHATEAsclemed USA, Inc.a7b7884a-6bd4-4d06-8f14-0759450c07242020-06-17Warnings, Adverse reactionsName fallback
generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium PhosphateDEXAMETHASONE SODIUM PHOSPHATEMylan Institutional LLC836f8017-d023-410b-8515-ec776e73ca592019-11-04Warnings, Adverse reactionsName fallback
brand name: Dexamethasone Sodium Phosphate
generic name: DEXAMETHASONE SODIUM PHOSPHATE

Reported adverse events (FAERS/openFDA)#

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