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Back to Companies who have applied for FDA Drug Approval
FDA Drug Approval Applications Sponsored by BAXTER HLTHCARE
Application Number
Drugs/Products
Application Type
Most Recent Label Available Flag
Current Patent Flag
Action Type
Chemical Type
Ther Potential
Orphan Code
006343
WYDASE
New Drug Application
Approval
New manufacturer
(S) Standard review drug
012141
CYTOXAN
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
012142
CYTOXAN
CYTOXAN (LYOPHILIZED)
LYOPHILIZED CYTOXAN
New Drug Application
Approval
New ester, new salt, or other noncovalent derivative
(P) Priority review drug
013684
OSMITROL 10% IN WATER
OSMITROL 10% IN WATER IN PLASTIC CONTAINER
OSMITROL 15% IN WATER
OSMITROL 15% IN WATER IN PLASTIC CONTAINER
OSMITROL 20% IN WATER
OSMITROL 20% IN WATER IN PLASTIC CONTAINER
OSMITROL 5% IN WATER
OSMITROL 5% IN WATER IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
016673
DEXTROSE 5% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
016677
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
016678
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
016679
LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
016682
LACTATED RINGER'S IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
016683
DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
016687
DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
016689
DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
016692
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
016693
RINGER'S IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
016694
DEXTROSE 10% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
016695
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
016696
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
016697
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
016717
TRAVERT 10% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017036
SODIUM HEPARIN
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017087
ETHRANE
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
017378
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER
PLASMA-LYTE A IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017385
PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017390
PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017427
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017428
STERILE WATER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017438
PLASMA-LYTE R IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017451
PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017484
DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017493
RENAMIN W/O ELECTROLYTES
TRAVASOL 10% W/O ELECTROLYTES
TRAVASOL 3.5% W/ ELECTROLYTES
TRAVASOL 5.5% W/ ELECTROLYTES
TRAVASOL 5.5% W/O ELECTROLYTES
TRAVASOL 8.5% W/ ELECTROLYTES
TRAVASOL 8.5% W/O ELECTROLYTES
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017512
DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017521
DEXTROSE 20% IN PLASTIC CONTAINER
DEXTROSE 30% IN PLASTIC CONTAINER
DEXTROSE 40% IN PLASTIC CONTAINER
DEXTROSE 50% IN PLASTIC CONTAINER
DEXTROSE 60% IN PLASTIC CONTAINER
DEXTROSE 70% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017624
FORANE
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
017634
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017648
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017863
SORBITOL 3% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017864
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017865
AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017866
STERILE WATER IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
017867
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018008
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018016
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018037
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018336
TIS-U-SOL IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018398
DOPAMINE HYDROCHLORIDE
New Drug Application
Approval
018461
LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER
New Drug Application
Approval
New formulation
(S) Standard review drug
018494
LACTATED RINGER'S IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018495
RINGER'S IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018497
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018508
TIS-U-SOL
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018512
SORBITOL 3% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018519
IRRIGATING SOLUTION G IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018522
GLYCINE 1.5% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018523
ACETIC ACID 0.25% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018581
SODIUM NITROPRUSSIDE
New Drug Application
Approval
018590
AMINOCAPROIC ACID
New Drug Application
Approval
018609
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018629
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018632
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018649
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER
New Drug Application
Approval
New combination
(S) Standard review drug
018657
FLAGYL I.V. RTU IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018660
TRAVAMULSION 10%
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018678
BRANCHAMIN 4%
New Drug Application
Approval
New formulation
(S) Standard review drug
018684
BRANCHAMIN 4% IN PLASTIC CONTAINER
New Drug Application
Approval
New formulation
(S) Standard review drug
018758
TRAVAMULSION 20%
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018814
HEPARIN SODIUM 10,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018840
DEXTROSE 5% AND ELECTROLYTE NO. 75 IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018921
LACTATED RINGER'S IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
018931
TRAVASOL 10% IN PLASTIC CONTAINER
TRAVASOL 5.5% IN PLASTIC CONTAINER
TRAVASOL 8.5% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
019022
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
019047
PLASMA-LYTE 56 IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
019308
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
019319
SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
019326
SYNOVALYTE IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
019367
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
019386
BREVIBLOC
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
BREVIBLOC IN PLASTIC CONTAINER
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
019520
TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER
TRAVASOL 2.75% IN DEXTROSE 15% IN PLASTIC CONTAINER
TRAVASOL 2.75% IN DEXTROSE 20% IN PLASTIC CONTAINER
TRAVASOL 2.75% IN DEXTROSE 25% IN PLASTIC CONTAINER
TRAVASOL 2.75% IN DEXTROSE 5% IN PLASTIC CONTAINER
TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER
TRAVASOL 4.25% IN DEXTROSE 15% IN PLASTIC CONTAINER
TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER
TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER
TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
019615
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
019763
IFEX
IFEX/MESNEX KIT
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
(V) Orphan drug
019837
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
019884
MESNEX
New Drug Application
Approval
New molecular entity (NME)
(P) Priority review drug
(V) Orphan drug
019904
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
019933
LACTATED RINGER'S IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
019970
NITROGLYCERIN IN DEXTROSE 5%
New Drug Application
Approval
New formulation
(S) Standard review drug
020047
DEXTROSE 50% IN PLASTIC CONTAINER
DEXTROSE 60% IN PLASTIC CONTAINER
DEXTROSE 70% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
020107
NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER
New Drug Application
Approval
020118
SUPRANE
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
020147
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
020163
DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
020173
TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
020177
TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
020178
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
020179
DEXTROSE 5% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
020183
DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
020255
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
020360
HEPATASOL 8%
Abbreviated New Drug Application
Approval
New manufacturer
(S) Standard review drug
020512
CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER
Abbreviated New Drug Application
Approval
New manufacturer
(S) Standard review drug
020678
CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER
CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER
CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER
CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER
New Drug Application
Approval
New combination
(S) Standard review drug
020734
CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER
CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER
CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER
CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER
New Drug Application
Approval
New combination
(S) Standard review drug
020849
PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER
New Drug Application
Approval
New formulation
(S) Standard review drug
020855
MESNEX
New Drug Application
Approval
New formulation
(S) Standard review drug
021321
EXTRANEAL
New Drug Application
Approval
New molecular entity (NME)
(S) Standard review drug
(V) Orphan drug
021703
PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER
PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER
PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER
PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER
PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER
PRISMASOL BGK 2/0 IN PLASTIC CONTAINER
PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER
PRISMASOL BGK 4/0 IN PLASTIC CONTAINER
PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER
PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER
PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER
PRISMASOL BK 0/0 IN PLASTIC CONTAINER
PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER
PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER
PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER
New Drug Application
Approval
New formulation
(S) Standard review drug
022325
NEXTERONE
New Drug Application
Approval
New formulation
(S) Standard review drug
040745
CYCLOPHOSPHAMIDE
Abbreviated New Drug Application
Approval
050566
ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER
ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
New Drug Application
Approval
New formulation
(S) Standard review drug
050638
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER
New Drug Application
Approval
New formulation
(S) Standard review drug
050640
BACTOCILL IN PLASTIC CONTAINER
New Drug Application
Approval
New formulation
(S) Standard review drug
050648
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
New Drug Application
Approval
New formulation
(S) Standard review drug
050655
NALLPEN IN PLASTIC CONTAINER
New Drug Application
Approval
New formulation
(S) Standard review drug
050671
VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER
New Drug Application
Approval
New formulation
(S) Standard review drug
050817
CEFEPIME IN PLASTIC CONTAINER
New Drug Application
Approval
New formulation
(S) Standard review drug
062373
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Abbreviated New Drug Application
Approval
062422
CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER
CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER
Abbreviated New Drug Application
Approval
062730
CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER
Abbreviated New Drug Application
Approval
062993
ERYTHROMYCIN LACTOBIONATE
Abbreviated New Drug Application
Approval
063002
ANCEF IN PLASTIC CONTAINER
Abbreviated New Drug Application
Approval
063221
CEFTAZIDIME SODIUM IN PLASTIC CONTAINER
Abbreviated New Drug Application
Approval
065224
CEFTRIAXONE IN PLASTIC CONTAINER
Abbreviated New Drug Application
Approval
070291
METHYLDOPATE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
073617
PENTAMIDINE ISETHIONATE
Abbreviated New Drug Application
Approval
074381
DOBUTAMINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
074629
IOPAMIDOL
Abbreviated New Drug Application
Approval
074719
PROPOFOL
Abbreviated New Drug Application
Tentative Approval
074824
ATRACURIUM BESYLATE
Abbreviated New Drug Application
Approval
074825
ATRACURIUM BESYLATE PRESERVATIVE FREE
Abbreviated New Drug Application
Approval
075323
CARDIOPLEGIC IN PLASTIC CONTAINER
Abbreviated New Drug Application
Approval
075591
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER
Abbreviated New Drug Application
Approval
075834
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Abbreviated New Drug Application
Approval
075880
PREMASOL 10% IN PLASTIC CONTAINER
PREMASOL 6% IN PLASTIC CONTAINER
Abbreviated New Drug Application
Approval
075895
SEVOFLURANE
Abbreviated New Drug Application
Approval
076259
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Abbreviated New Drug Application
Approval
076766
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Abbreviated New Drug Application
Approval
077888
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Abbreviated New Drug Application
Approval
080203
POTASSIUM CHLORIDE
Abbreviated New Drug Application
Approval
083256
ALCOHOL 5% IN DEXTROSE 5% IN WATER
Abbreviated New Drug Application
Approval
083486
ISOPROTERENOL HYDROCHLORIDE
Abbreviated New Drug Application
Approval
084767
DIMENHYDRINATE
Abbreviated New Drug Application
Approval
085499
POTASSIUM CHLORIDE
Abbreviated New Drug Application
Approval
085551
HYDROXYZINE
HYDROXYZINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
086619
HYDROCORTISONE SODIUM SUCCINATE
Abbreviated New Drug Application
Approval
087567
HYDROCORTISONE SODIUM SUCCINATE
Abbreviated New Drug Application
Approval
087568
HYDROCORTISONE SODIUM SUCCINATE
Abbreviated New Drug Application
Approval
087569
HYDROCORTISONE SODIUM SUCCINATE
Abbreviated New Drug Application
Approval
087759
PROCHLORPERAZINE
Abbreviated New Drug Application
Approval
088144
ISOETHARINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088145
ISOETHARINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088146
ISOETHARINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088279
MEPERIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088280
MEPERIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088281
MEPERIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088282
MEPERIDINE HYDROCHLORIDE
Abbreviated New Drug Application
Approval
088371
CYCLOPHOSPHAMIDE
Abbreviated New Drug Application
Approval
088372
CYCLOPHOSPHAMIDE
Abbreviated New Drug Application
Approval
088373
CYCLOPHOSPHAMIDE
Abbreviated New Drug Application
Approval
088374
CYCLOPHOSPHAMIDE
Abbreviated New Drug Application
Approval
204508
CLINOLIPID 20%
New Drug Application
Approval
New manufacturer
(P) Priority review drug
207026
PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER
PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
207131
CEFAZOLIN IN PLASTIC CONTAINER
New Drug Application
Approval
New manufacturer
(S) Standard review drug
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