FDA.reportPublic FDA data

Application 213561

Type
ANDA
Sponsor
HIKMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9990ATROPINE SULFATEatropine sulfate injectionHenry Schein, Inc.ANDACurrent
0641-6251Atropine SulfateAtropine SulfateHikma Pharmaceuticals USA Inc.ANDACurrent
51662-1619ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1619ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent