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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by GE HEALTHCARE
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
008032
TELEPAQUE
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
009561
HYPAQUE
HYPAQUE SODIUM 20%
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
010220
HYPAQUE-M,75%
HYPAQUE-M,90%
New Drug Application
Approval
New manufacturer
(S) Standard review drug
011386
HYPAQUE
New Drug Application
Approval
New formulation
(S) Standard review drug
013731
BILOPAQUE
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
016403
HYPAQUE
HYPAQUE-CYSTO
New Drug Application
Approval
New formulation
(P) Priority review drug
016847
ISOPAQUE 440
New Drug Application
Approval
New ester, new salt, or other noncovalent derivative; New combination
(S) Standard review drug
017042
FLUORINE F-18
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
017255
MPI DTPA KIT - CHELATE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017256
XENON XE 133
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017257
SELENOMETHIONINE SE 75
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017264
TECHNETIUM TC-99M PENTETATE KIT
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017406
DICOPAC KIT
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017456
TECHNETIUM TC 99M SULFUR COLLOID
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017471
SODIUM PERTECHNETATE TC 99M
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017506
ISOPAQUE 280
New Drug Application
Approval
New combination
(S) Standard review drug
017562
TECHNETIUM TC 99M DIPHOSPHONATE-TIN KIT
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017630
SODIUM IODIDE I 123
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
017653
CINTICHEM TECHNETIUM 99M HEDSPA
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017655
NEOSCAN
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017664
SODIUM POLYPHOSPHATE-TIN KIT
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017667
MPI STANNOUS DIPHOSPHONATE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017687
XENON XE 133
XENON XE 133-V.S.S.
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017693
TECHNETIUM TC 99M GENERATOR
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017700
GALLIUM CITRATE GA 67
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017707
MPI INDIUM DTPA IN 111
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
017773
TECHNETIUM TC 99M MAA
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017775
TECHNETIUM TC 99M HSA
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017784
TECHNETIUM TC 99M TSC
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017838
LUNGAGGREGATE REAGENT
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017848
TC 99M-LUNGAGGREGATE
New Drug Application
Approval
New formulation
(S) Standard review drug
017879
IBRIN
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017944
MPI DMSA KIDNEY REAGENT
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
017982
AMIPAQUE
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
018088
MPI KRYPTON 81M GENERATOR
New Drug Application
Approval
New ester, new salt, or other noncovalent derivative
(P) Priority review drug
018110
THALLOUS CHLORIDE TL 201
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018141
TECHNETIUM TC 99M MPI MDP
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018289
NEPHROFLOW
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
018335
AMERSCAN MDP KIT
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018956
OMNIPAQUE 140
OMNIPAQUE 180
OMNIPAQUE 210
OMNIPAQUE 240
OMNIPAQUE 300
OMNIPAQUE 350
OMNIPAQUE 70
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
019044
INDIUM IN 111 OXYQUINOLINE
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
019829
CERETEC
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
019862
INDICLOR
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
020123
OMNISCAN
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
020134
METASTRON
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
020351
VISIPAQUE 270
VISIPAQUE 320
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
020372
MYOVIEW
MYOVIEW 30ML
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
020608
OMNIPAQUE 240
OMNIPAQUE 300
OMNIPAQUE 350
New Drug Application
Approval
New manufacturer
(S) Standard review drug
020652
TESLASCAN
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
020808
VISIPAQUE 270
VISIPAQUE 320
New Drug Application
Approval
New formulation
(S) Standard review drug
020899
OPTISON
New Drug Application
Approval
New formulation
(S) Standard review drug
022066
OMNISCAN
New Drug Application
Approval
New manufacturer
(S) Standard review drug
022290
ADREVIEW
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
(V) Orphan drug
086505
HYPAQUE-76
Abbreviated New Drug Application
Approval
203137
VIZAMYL
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
Back to Companies who have applied for FDA Drug Approval