FDA.reportPublic FDA data

Application 209260

Type
NDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATROPINE SULFATEATROPINE SULFATESOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL8MG/20ML (0.4MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-580Atropine SulfateAtropine SulfateFresenius Kabi USA, LLCNDACurrent
63323-580Atropine SulfateAtropine SulfateFresenius Kabi USA, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59651ORIG2019-08-09
52131ORIG2018-01-30
52080ORIG2018-01-30