FDA.reportPublic FDA data

Application 022450

Type
NDA
Sponsor
MALLINCKRODT HOSP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OFIRMEVACETAMINOPHENSOLUTION;INTRAVENOUS1GM/100ML (10MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43825-102OfirmevacetaminophenMallinckrodt Hospital Products Inc.NDACurrent
43825-102OfirmevacetaminophenMallinckrodt Hospital ProNDACurrent
43825-102OfirmevacetaminophenMallinckrodt Hospital Products Inc.NDACurrent
43825-102OfirmevacetaminophenMallinckrodt Hospital Products Inc.NDACurrent
43825-102OfirmevacetaminophenMallinckrodt Hospital Products Inc.NDACurrent
43825-102OfirmevacetaminophenMallinckrodt Hospital Products Inc.NDACurrent
51662-1424OFIRMEV (ACETAMINOPHEN)OFIRMEV (ACETAMINOPHEN)HF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1424OFIRMEV (ACETAMINOPHEN)OFIRMEV (ACETAMINOPHEN)HF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56011SUPPL2018-10-18
53659SUPPL2018-04-12
47039SUPPL2017-01-31
47028SUPPL2017-01-27
51143SUPPL2015-03-30
38718SUPPL2013-10-22
17595SUPPL2013-10-22
29736SUPPL2013-10-21
7404SUPPL2013-10-21
51137SUPPL2011-12-08
42530ORIG2011-04-04
24312ORIG2011-04-04
51136SUPPL2010-12-20
29735ORIG2010-11-08
38717ORIG2010-11-05
51132SUPPL2007-08-24
66976ORIG1900-01-01
54093SUPPL1900-01-01
51428SUPPL1900-01-01
51427SUPPL1900-01-01
51426SUPPL1900-01-01