FDA.reportPublic FDA data

Application 202106

Type
NDA
Sponsor
B BRAUN MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINERMEROPENEMPOWDER;INTRAVENOUS500MG/VIALNoNo
002MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINERMEROPENEMPOWDER;INTRAVENOUS1GM/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0264-3183Meropenem and Sodium ChlorideMeropenem and Sodium ChlorideB. Braun Medical Inc.NDACurrent
0264-3183Meropenem and Sodium ChlorideMeropenem and Sodium ChlorideB. Braun Medical Inc.NDACurrent
0264-3183Meropenem and Sodium ChlorideMeropenem and Sodium ChlorideB. Braun Medical Inc.NDACurrent
0264-3183Meropenem and Sodium ChlorideMeropenem and Sodium ChlorideB. Braun Medical Inc.NDACurrent
0264-3185Meropenem and Sodium ChlorideMeropenem and Sodium ChlorideB. Braun Medical Inc.NDACurrent
0264-3185Meropenem and Sodium ChlorideMeropenem and Sodium ChlorideB. Braun Medical Inc.NDACurrent
0264-3185Meropenem and Sodium ChlorideMeropenem and Sodium ChlorideB. Braun Medical Inc.NDACurrent
0264-3185Meropenem and Sodium ChlorideMeropenem and Sodium ChlorideB. Braun Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80518SUPPL 2024-12-05
80495SUPPL 2024-12-04
62955SUPPL2020-05-13
62954SUPPL2020-05-13
62939SUPPL2020-05-13
51871SUPPL2018-01-26
51376SUPPL2018-01-22
44843ORIG2015-12-09
43384ORIG2015-12-09
40121ORIG2015-05-06
9961ORIG2015-05-05