FDA.reportPublic FDA data

Application 022485

Type
NDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARGATROBAN IN SODIUM CHLORIDEARGATROBANINJECTABLE;INTRAVENOUS125MG/125ML (1MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3285ArgatrobanArgatrobanSandoz IncNDACurrent
0781-3285ArgatrobanArgatrobanSandoz IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58477SUPPL2019-04-30
58480SUPPL2019-04-29
55862SUPPL2018-10-10
54784SUPPL2018-07-06
38758SUPPL2016-06-01
29772SUPPL2016-05-27
44760ORIG2012-01-05
42536ORIG2012-01-05
7456ORIG2011-05-12
17638ORIG2011-05-09
29771ORIG2011-01-19