FDA.reportPublic FDA data

Application 206171

Type
ANDA
Sponsor
SPECTRA MDCL DEVICES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM CHLORIDE 0.9%SODIUM CHLORIDEINJECTABLE;INJECTION9MG/MLNoNo
002SODIUM CHLORIDE 0.9%SODIUM CHLORIDESOLUTION;INJECTION90MG/10ML (9MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65282-1505Sodium ChlorideSodium ChlorideSpectra Medical Devices, ANDACurrent
65282-1505Sodium ChlorideSodium ChlorideSpectra Medical Devices, Inc.ANDACurrent
65282-1505Sodium ChlorideSodium ChlorideSpectra Medical Devices, Inc.ANDACurrent
65282-1505Sodium ChlorideSodium ChlorideSpectra Medical Devices, Inc.ANDACurrent
65282-1505Sodium ChlorideSodium ChlorideSpectra Medical Devices, Inc.ANDACurrent
65282-1505Sodium ChlorideSodium ChlorideSpectra Medical Devices, LLCANDACurrent
65282-1505Sodium ChlorideSodium ChlorideSpectra Medical Devices, LLCANDACurrent
65282-1510Sodium ChlorideSodium ChlorideSpectra Medical Devices, ANDACurrent
65282-1510Sodium ChlorideSodium ChlorideSpectra Medical Devices, Inc.ANDACurrent
65282-1510Sodium ChlorideSodium ChlorideSpectra Medical Devices, Inc.ANDACurrent
65282-1510Sodium ChlorideSodium ChlorideSpectra Medical Devices, Inc.ANDACurrent
65282-1510Sodium ChlorideSodium ChlorideSpectra Medical Devices, Inc.ANDACurrent
65282-1510Sodium ChlorideSodium ChlorideSpectra Medical Devices, LLCANDACurrent
65282-1510Sodium ChlorideSodium ChlorideSpectra Medical Devices, LLCANDACurrent