FDA.reportPublic FDA data

Application 022434

Type
NDA
Sponsor
EAGLE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARGATROBAN IN SODIUM CHLORIDEARGATROBANINJECTABLE;INTRAVENOUS50MG/50ML (1MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3314ArgatrobanArgatrobanSandoz IncNDACurrent
0781-3314ArgatrobanArgatrobanSandoz IncNDACurrent
0781-3314ArgatrobanArgatrobanSandoz IncNDACurrent
0781-9314ArgatrobanArgatrobanSandoz IncNDACurrent
0781-9314ArgatrobanArgatrobanSandoz IncNDACurrent
0781-9314ArgatrobanArgatrobanSandoz IncNDACurrent
42367-202ArgatrobanArgatrobanEagle Pharmaceuticals, Inc.NDACurrent
42367-202ArgatrobanArgatrobanEagle Pharmaceuticals, Inc.NDACurrent
42367-202ArgatrobanArgatrobanEagle Pharmaceuticals, Inc.NDACurrent
42367-202ArgatrobanArgatrobanEagle Pharmaceuticals, Inc.NDACurrent
42367-203ArgatrobanArgatrobanEagle Pharmaceuticals, Inc.NDACurrent
42367-203ArgatrobanArgatrobanEagle Pharmaceuticals, Inc.NDACurrent
42367-203ArgatrobanArgatrobanEagle Pharmaceuticals, Inc.NDACurrent
42367-203ArgatrobanArgatrobanEagle Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61213SUPPL2019-12-10
61205SUPPL2019-12-10
54678SUPPL2018-06-22
54641SUPPL2018-06-21
38713SUPPL2016-06-01
29729SUPPL2016-05-27
38712SUPPL2014-09-11
7398SUPPL2014-09-10
42527ORIG2011-11-22
24308ORIG2011-11-22
7397ORIG2011-07-06
38711ORIG2011-06-30