FDA.reportPublic FDA data

Application 022325

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEXTERONEAMIODARONE HYDROCHLORIDEINJECTABLE;INJECTION50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002NEXTERONEAMIODARONE HYDROCHLORIDEINJECTABLE;INJECTION150MG/100ML (1.5MG/ML)YesYes
003NEXTERONEAMIODARONE HYDROCHLORIDEINJECTABLE;INJECTION360MG/200ML (1.8MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43066-150Nexteroneamiodarone hydrochlorideBaxter Healthcare CorporationNDACurrent
43066-150Nexteroneamiodarone hydrochlorideBaxter Healthcare CorporationNDACurrent
43066-150Nexteroneamiodarone hydrochlorideBaxter Healthcare CorporationNDACurrent
43066-150Nexteroneamiodarone hydrochlorideBaxter Healthcare CorporationNDACurrent
43066-150Nexteroneamiodarone hydrochlorideBaxter Healthcare CorporationNDACurrent
43066-150Nexteroneamiodarone hydrochlorideBaxter Healthcare CorporationNDACurrent
43066-360Nexteroneamiodarone hydrochlorideBaxter Healthcare CorporationNDACurrent
43066-360Nexteroneamiodarone hydrochlorideBaxter Healthcare CorporationNDACurrent
43066-360Nexteroneamiodarone hydrochlorideBaxter Healthcare CorporationNDACurrent
43066-360Nexteroneamiodarone hydrochlorideBaxter Healthcare CorporationNDACurrent
43066-360Nexteroneamiodarone hydrochlorideBaxter Healthcare CorporationNDACurrent
43066-360Nexteroneamiodarone hydrochlorideBaxter Healthcare CorporationNDACurrent
51662-1480NEXTERONE (AMIODARONE HCI)NEXTERONE (AMIODARONE HCI)HF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1480NEXTERONE (AMIODARONE HCI)NEXTERONE (AMIODARONE HCI)HF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1481NEXTERONE (AMIODARONE HCI)NEXTERONE (AMIODARONE HCI)HF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1481NEXTERONE (AMIODARONE HCI)NEXTERONE (AMIODARONE HCI)HF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81364SUPPL 2025-02-25
81355SUPPL 2025-02-25
68574SUPPL2021-09-10
68562SUPPL2021-09-08
50610SUPPL2017-12-06
47703SUPPL2017-03-24
47678SUPPL2017-03-24
46001SUPPL2016-12-02
45954SUPPL2016-11-23
38576SUPPL2015-03-17
29596SUPPL2015-03-17
29595SUPPL2011-12-14
38575SUPPL2011-12-12
7237SUPPL2010-11-22
17242SUPPL2010-11-18
24283ORIG2010-02-17
21993ORIG2010-02-17
38574ORIG2009-01-02
7236ORIG2009-01-02