FDA.reportPublic FDA data

Application 018140

Type
NDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATIVANLORAZEPAMINJECTABLE;INJECTION2MG/MLYesYes
002ATIVANLORAZEPAMINJECTABLE;INJECTION4MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-6000AtivanLorazepamWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6000AtivanLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6000AtivanLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6000AtivanLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6001AtivanLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6001AtivanLorazepamWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6001AtivanLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6001AtivanLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6002AtivanLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6002AtivanLorazepamWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6002AtivanLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6002AtivanLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6003AtivanLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6003AtivanLorazepamWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6003AtivanLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6003AtivanLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6044LorazepamLorazepamWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6044LorazepamLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6045LorazepamLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6045LorazepamLorazepamWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6046LorazepamLorazepamWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6046LorazepamLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6047LorazepamLorazepamWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6047LorazepamLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6048LorazepamLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6048LorazepamLorazepamWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6049LorazepamLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6049LorazepamLorazepamWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6050LorazepamLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6050LorazepamLorazepamWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6051LorazepamLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6051LorazepamLorazepamWest-Ward Pharmaceuticals Corp.NDACurrent
0641-6207LorazepamLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6207LorazepamLorazepamHikma Pharmaceuticals USA Inc.NDACurrent
0641-6207LorazepamLorazepamWest-Ward Pharmaceuticals Corp.NDACurrent
64725-6044LorazepamLorazepamTYA PharmaceuticalsNDACurrent
72572-380LorazepamLorazepamCivica, Inc.NDACurrent
72572-380LorazepamLorazepamCivica, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73226SUPPL2023-01-17
73170SUPPL2023-01-17
66160SUPPL2021-02-09
66129SUPPL2021-02-09
48224SUPPL2017-05-02
48223SUPPL2017-05-02
48195SUPPL2017-05-02
48194SUPPL2017-05-02
47209SUPPL2017-02-15
14917SUPPL2016-05-31
40780SUPPL2007-04-09
850SUPPL2006-12-28
11167SUPPL2006-12-04
20110SUPPL1997-10-05