FDA.reportPublic FDA data

Application 203351

Type
ANDA
Sponsor
OHM LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM OXYBATESODIUM OXYBATESOLUTION;ORAL500MG/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 1 of 1 ยท 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sodium oxybateSODIUM OXYBATECamber Pharmaceuticals, Inc.5dcf9a5c-312b-420b-82f3-42177d8f9ee42026-04-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: sodium oxybate
generic name: SODIUM OXYBATE
sodium oxybateSODIUM OXYBATEXLCare Pharmaceuticals, Inc.c0fb2620-7247-464d-a37a-8b516ce7d5632026-01-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: sodium oxybate
generic name: SODIUM OXYBATE
LumryzSODIUM OXYBATEAvadel CNS Pharmaceuticals, LLC10e5e40c-52f3-4c73-8a34-2c29c690a9342025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SODIUM OXYBATE
XyremSODIUM OXYBATEJazz Pharmaceuticals, Inc.926eb076-a4a8-45e4-91ef-411f0aa4f3ca2025-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SODIUM OXYBATE
Sodium OxybateSODIUM OXYBATEAmneal Pharmaceuticals LLC5a9e9045-f04d-46eb-8396-2495c6090a312025-05-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sodium Oxybate
generic name: SODIUM OXYBATE
sodium oxybateSODIUM OXYBATEHikma Pharmaceuticals USA Inc.bcef2c95-35e9-464d-9025-652acff769e72023-04-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: sodium oxybate
generic name: SODIUM OXYBATE