FDA.reportPublic FDA data

Application 008845

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUELICIN PRESERVATIVE FREESUCCINYLCHOLINE CHLORIDEINJECTABLE;INJECTION20MG/MLYesNo
002QUELICIN PRESERVATIVE FREESUCCINYLCHOLINE CHLORIDEINJECTABLE;INJECTION50MG/MLNoNo
004QUELICIN PRESERVATIVE FREESUCCINYLCHOLINE CHLORIDEINJECTABLE;INJECTION100MG/MLNoNo
006QUELICINSUCCINYLCHOLINE CHLORIDEINJECTABLE;INJECTION20MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-6629QUELICINSuccinylcholine ChlorideHospira, Inc.NDACurrent
0409-6629QUELICINSuccinylcholine ChlorideHospira, Inc.NDACurrent
0409-6629QuelicinSuccinylcholine ChlorideHospira, Inc.NDACurrent
0409-6629QUELICINSuccinylcholine ChlorideHospira, Inc.NDACurrent
0409-6629QUELICINSuccinylcholine ChlorideHospira, Inc.NDACurrent
0409-6629QUELICINSuccinylcholine ChlorideHospira, Inc.NDACurrent
0409-6629QUELICINSuccinylcholine ChlorideHospira, Inc.NDACurrent
0409-6629QuelicinSuccinylcholine ChlorideHospira, Inc.NDACurrent
0409-6629QUELICINSuccinylcholine ChlorideHospira, Inc.NDACurrent
0409-6629QuelicinSuccinylcholine ChlorideHospira, Inc.NDACurrent
51662-1353SUCCINYLCHOLINE CHLORIDESUCCINYLCHOLINE CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1353SUCCINYLCHOLINE CHLORIDESUCCINYLCHOLINE CHLORIDEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
71872-7026QuelicinSuccinylcholine ChlorideMedical Purchasing Solutions, LLCNDACurrent
71872-7026QuelicinSuccinylcholine ChlorideMedical Purchasing Solutions, LLCNDACurrent
71872-7146QuelicinSuccinylcholine ChlorideMedical Purchasing Solutions, LLCNDACurrent
71872-7146QuelicinSuccinylcholine ChlorideMedical Purchasing Solutions, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72541SUPPL2022-11-02
72529SUPPL2022-11-02
70236SUPPL2022-02-23
70225SUPPL2022-02-22
68352SUPPL2021-08-12
68348SUPPL2021-08-12
55043SUPPL2018-07-30
55027SUPPL2018-07-27
117SUPPL2010-11-30
32979SUPPL2010-11-22