FDA.reportPublic FDA data

Application 203049

Type
NDA
Sponsor
HIKMA PHARM CO LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARGATROBANARGATROBANINJECTABLE;INJECTION250MG/2.5ML (100MG/ML)YesYes
002ARGATROBANARGATROBANINJECTABLE;INJECTION50MG/50ML (1MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9288ArgatrobanArgatrobanWest-Ward Pharmaceuticals CorpNDACurrent
0143-9288ArgatrobanArgatrobanHikma Pharmaceuticals USA Inc.NDACurrent
0143-9288ArgatrobanArgatrobanHikma Pharmaceuticals USA Inc.NDACurrent
0143-9377ArgatrobanArgatrobanHikma Pharmaceuticals USA Inc.NDACurrent
0143-9377ArgatrobanArgatrobanHikma Pharmaceuticals USA Inc.NDACurrent
0143-9377ArgatrobanArgatrobanHikma Pharmaceuticals USA Inc.NDACurrent
0143-9559ArgatrobanArgatrobanWest-Ward Pharmaceuticals CorpNDACurrent
0143-9559ArgatrobanArgatrobanHikma Pharmaceuticals USA Inc.NDACurrent
0143-9559ArgatrobanArgatrobanHikma Pharmaceuticals USA Inc.NDACurrent
0143-9559ArgatrobanArgatrobanHikma Pharmaceuticals USA Inc.NDACurrent
0143-9559ArgatrobanArgatrobanHikma Pharmaceuticals USA Inc.NDACurrent
0143-9674ArgatrobanArgatrobanWest-Ward Pharmaceuticals CorpNDACurrent
0143-9674ArgatrobanArgatrobanHikma Pharmaceuticals USA Inc.NDACurrent
0143-9674ArgatrobanArgatrobanHikma Pharmaceuticals USA Inc.NDACurrent
0143-9674ArgatrobanArgatrobanHikma Pharmaceuticals USA Inc.NDACurrent
0143-9674ArgatrobanArgatrobanHikma Pharmaceuticals USA Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85969SUPPL 2026-05-19
85961SUPPL 2026-05-19
62650SUPPL2020-04-23
62645SUPPL2020-04-23
48862SUPPL2017-06-29
45582SUPPL2016-10-06
45448SUPPL2016-10-03
19414SUPPL2016-06-01
32362SUPPL2016-05-27
24424ORIG2013-06-04
22907ORIG2013-06-04
32361ORIG2012-01-09
40254ORIG2012-01-06