FDA.reportPublic FDA data

Application 019632

Type
NDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LACTATED RINGER'S IN PLASTIC CONTAINERCALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATEINJECTABLE;INJECTION20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0264-7750Lactated RingersSodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium ChlorideB. Braun Medical Inc.NDACurrent
0264-7750Lactated RingersSodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium ChlorideB. Braun Medical Inc.NDACurrent
0264-7750Lactated RingersSodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium ChlorideB. Braun Medical Inc.NDACurrent
0264-7750Lactated RingersSodium Chloride, Sodium Lactate, Potassium Chloride, and Calcium ChlorideB. Braun Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84112SUPPL 2025-11-06
84080SUPPL 2025-11-06
69251SUPPL2021-11-05
69224SUPPL2021-11-04