FDA.reportPublic FDA data

Application 020372

Type
NDA
Sponsor
GE HEALTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYOVIEWTECHNETIUM TC-99M TETROFOSMIN KITINJECTABLE;INJECTIONN/AYesNo
002MYOVIEW 30MLTECHNETIUM TC-99M TETROFOSMIN KITINJECTABLE;INJECTIONN/AYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17156-024MyoviewTetrofosminMedi-Physics Inc. dba GE HealthcareNDACurrent
17156-024MyoviewTetrofosminMedi-Physics Inc. dba GE HealthcareNDACurrent
17156-024MyoviewTetrofosminMedi-Physics Inc. dba GE HealthcareNDACurrent
17156-026MyoviewTetrofosminMedi-Physics Inc. dba GE HealthcareNDACurrent
17156-026MyoviewTetrofosminMedi-Physics Inc. dba GE HealthcareNDACurrent
17156-026MyoviewTetrofosminMedi-Physics Inc. dba GE HealthcareNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72829SUPPL2022-12-08
72817SUPPL2022-12-07
70551SUPPL2022-03-17
70470SUPPL2022-03-10
48061SUPPL2017-04-18
48053SUPPL2017-04-18
34568SUPPL2009-03-17
24859SUPPL2009-03-05
24858SUPPL2005-07-15
12496SUPPL2005-07-15
34567SUPPL2003-12-01
2405SUPPL2003-11-26
20613SUPPL2003-07-08
12495SUPPL2003-04-22
2404SUPPL2003-03-10
34566SUPPL2003-03-05
24857SUPPL2002-05-22
20612SUPPL2002-03-12
34565SUPPL2001-11-03
2403SUPPL2001-11-03