FDA.reportPublic FDA data

Application 010515

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISUPRELISOPROTERENOL HYDROCHLORIDEINJECTABLE;INJECTION0.2MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-4330IsuprelIsoproterenol hydrochlorideBausch Health Americas, Inc.NDACurrent
0187-4330IsuprelIsoproterenol hydrochlorideBausch Health US LLCNDACurrent
0187-4330IsuprelIsoproterenol hydrochlorideBausch Health US LLCNDACurrent
0187-4330IsuprelIsoproterenol hydrochlorideBausch Health US LLCNDACurrent
0187-4330IsuprelIsoproterenol hydrochlorideBausch Health US LLCNDACurrent
0187-4330IsuprelIsoproterenol hydrochlorideValeant Pharmaceuticals North America LLCNDACurrent
0187-4330IsuprelIsoproterenol hydrochlorideBausch Health US LLCNDACurrent
68682-433Isoproterenol HydrochlorideIsoproterenol hydrochlorideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72460SUPPL2022-10-24
72434SUPPL2022-10-21
49496APPL2017-08-22
40665SUPPL2015-11-17
40664SUPPL2015-11-05
40663SUPPL2015-11-05
10752SUPPL2013-03-26
40662SUPPL1999-05-05
11904SUPPL1999-05-04
10751SUPPL1999-05-04