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Approved Drug Products |
U.S. Food and Drug Administration • Center for Drug Evaluation and Research |
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Approved Drug Products |
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DRUG PRODUCTS
WITH APPROVAL UNDER SECTION 505 OF THE ACT ADMINISTERED BY THE CENTER
FOR BIOLOGICS EVALUATION AND RESEARCH LIST
| ANTICOAGULANT
CITRATE DEXTROSE SOLUTION (ACD) INJECTABLE; INJECTION ACD-A SOLUTION GAMBRO BCT, INC ANDA
|
ANTICOAGULANT
CITRATE DEXTROSE SOLUTION (ACD) INJECTABLE; INJECTION ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A HAEMONETICS CORP ANDA
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| ANTICOAGULANT
CITRATE DEXTROSE SOLUTION USP INJECTABLE; INJECTION NONE MEDSEP CORPORATION ANDA |
ANTICOAGULANT
CITRATE DEXTROSE SOLUTION USP INJECTABLE; INJECTION NONE MILES, INC N100102 |
| ANTICOAGULANT
CITRATE DEXTROSE SOLUTION USP INJECTABLE; INJECTION NONE FRESENIUS USA, INC N110912 |
ANTICOAGULANT
CITRATE DEXTROSE SOLUTION USP INJECTABLE; INJECTION NONE BAXTER HEALTHCARE CORP - FENWAL DIVISION N100855 |
| ANTICOAGULANT
CITRATE DEXTROSE SOLUTION USP INJECTABLE; INJECTION NONE BAXTER HEALTHCARE CORP - FENWAL DIVISION N160918 |
ANTICOAGULANT
CITRATE PHOSPHATE 2X DEXTROSE SOLUTION (CP2D) INJECTABLE; INJECTION CITRATE PHOSPHATE DOUBLE DEXTROSE/ADDITIVE SOLUTION 3 HAEMONETICS CORP N000127
|
| ANTICOAGULANT
CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION INJECTABLE; INJECTION NONE FRESENIUS USA, INC N780519
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ANTICOAGULANT
CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION INJECTABLE; INJECTION NONE TERUMO MEDICAL CORP N820528
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| ANTICOAGULANT
CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION INJECTABLE; INJECTION NONE BAXTER HEALTHCARE CORP - FENWAL DIVISION N770420
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ANTICOAGULANT
CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION USP INJECTABLE; INJECTION BLOOD PACK UNIT CPDA-1 IN PLASTIC CONTAINER BAXTER HEALTHCARE - FENWAL DIVISION N940404 |
| ANTICOAGULANT
CITRATE PHOSPHATE DEXTROSE ADENINE-1 SOLUTION INJECTABLE; INJECTION NONE MEDSEP CORPORATION N800077 |
ANTICOAGULANT
CITRATE PHOSPHATE DEXTROSE SOLUTION USP INJECTABLE; INJECTION NONE MILES, INC N160527 |
| ANTICOAGULANT
CITRATE PHOSPHATE DEXTROSE SOLUTION USP INJECTABLE; INJECTION NONE MEDSEP CORPORATION N800222 |
ANTICOAGULANT
CITRATE PHOSPHATE DEXTROSE SOLUTION USP INJECTABLE; INJECTION NONE FRESENIUS USA, INC N160907 |
| ANTICOAGULANT
CITRATE PHOSPHATE DEXTROSE SOLUTION USP INJECTABLE; INJECTION NONE TERUMO MEDICAL CORP N781211 |
ANTICOAGULANT
CITRATE PHOSPHATE DEXTROSE SOLUTION USP INJECTABLE; INJECTION NONE BAXTER HEALTHCARE CORP - FENWAL DIVISION N170401 |
| ANTICOAGULANT
CITRATE PHOSPHATE DEXTROSE SOLUTION USP INJECTABLE; INJECTION NONE BAXTER HEALTHCARE CORP - FENWAL DIVISION N811012 |
ANTICOAGULANT
CITRATE PHOSPHATE DEXTROSE SOLUTION USP WITH: AS-1: DEXTROSE USP; SODIUM CHLORIDE USP;
MANNITOL USP; ADENINE INJECTABLE; INJECTION ADSOL RED BLOOD CELL PRESERVATIVE SOLUTION BAXTER HEALTHCARE CORP - FENWAL DIVISION 2.2GM/100ML; N811104 |
| ANTICOAGULANT
CITRATE PHOSPHATE DEXTROSE SOLUTION USP WITH: AS-5: DEXTROSE USP; SODIUM CHLORIDE USP;
MANNITOL USP; ADENINE INJECTABLE; INJECTION OPTISOL RED BLOOD CELL PRESERVATIVE SOLUTION TERUMO MEDICAL CORP 0.9GM/100ML; N880217 |
ANTICOAGULANT
CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION WITH: AS-2: CITRIC ACID USP; DIBASIC SODIUM
PHOSPHATE USP; SODIUM CHLORIDE USP; ADENINE; DEXTROSE USP; SODIUM CITRATE USP INJECTABLE; INJECTION AS-2 NUTRICEL ADDITIVE SYSTEM MEDSEP CORP 0.042GM/100ML; N820915 |
| ANTICOAGULANT
CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION WITH: AS-3: CITRIC ACID USP; MONOBASIC SODIUM
PHOSPHATE USP; SODIUM CHLORIDE USP; ADENINE; DEXTROSE USP; SODIUM CITRATE USP INJECTABLE; INJECTION AS-3 NUTRICEL ADDITIVE SYSTEM MEDSEP CORP 0.042GM/100ML; N820915 |
ANTICOAGULANT
CITRATE PHOSPHATE DEXTROSE SOLUTION INJECTABLE; INJECTION CDP BLOOD BAG UNIT IN PLASTIC CONTAINER BAXTER HEALTHCARE - FENWAL DIVISION N900224 |
| ANTICOAGULANT
CITRATE PHOSPHATE DEXTROSE SOLUTION INJECTABLE; INJECTION ADSOL IN PLASTIC CONTAINER BAXTER HEALTHCARE - FENWAL DIVISION N900223 |
ANTICOAGULANT
HEPARIN SOLUTION USP INJECTABLE; INJECTION NONE FRESENIUS USA, INC N770822 |
| ANTICOAGULANT
4% SODIUM CITRATE SOLUTION USP INJECTABLE; INJECTION NONE MEDSEP CORPORATION N760305 |
ANTICOAGULANT
SODIUM CITRATE 4% SOLUTION INJECTABLE; INJECTION NONE HAEMONETICS CORPORATION N980123 |
| ANTICOAGULANT
SODIUM CITRATE SOLUTION USP INJECTABLE; INJECTION NONE ALPHA THERPTC N810416 |
ANTICOAGULANT
SODIUM CITRATE SOLUTION USP INJECTABLE; INJECTION NONE FRESENIUS USA, INC N160702 |
| ANTICOAGULANT
SODIUM CITRATE SOLUTION USP INJECTABLE; INJECTION NONE TERUMO MEDICAL CORP N781214 |
ANTICOAGULANT
SODIUM CITRATE SOLUTION USP INJECTABLE; INJECTION NONE BAXTER HEALTHCARE CORP - FENWAL DIVISION N770923 |
| DEXTRAN
1 IN SODIUM CHLORIDE 0.6% INJECTABLE; INJECTION PROMIT PHARMALINK BASLAKEMEDEL AB 150MG/ML; N830715 |
DEXTRAN
40, 10% W/V DEXTRAN 40 IN 0.8% NACL 500 ML PVC BAGS INJECTABLE; INJECTION RHEOMACRODEX PHARMALINK BASLAKEMEDEL AB N830527 |
| DEXTRAN
40, 10% W/V DEXTRAN 40 IN 5% DEXTROSE 500 ML PVC BAGS INJECTABLE; INJECTION RHEOMACRODEX PHARMALINK BASLAKEMEDEL AB N830627 |
DEXTRAN
40, 10% IN DEXTROSE 5% INJECTABLE; INJECTION GENTRAN 40 BAXTER HEALTHCARE - IV SYSTEMS 10GM/100ML; N840619 |
| DEXTRAN
40, 10% IN DEXTROSE 5% INJECTABLE; INJECTION LMD IN PLASTIC CONTAINER ABBOTT LABS 10GM/100ML; ANDA |
DEXTRAN
40, 10% IN DEXTROSE 5% INJECTABLE; INJECTION NONE ABBOTT LABS 10GM/100ML; N160375 |
| DEXTRAN
40, 10% IN DEXTROSE 5% INJECTABLE; INJECTION NONE MCGAW, INC 10GM/100ML; N160767 |
DEXTRAN
40, 10% IN DEXTROSE 5% INJECTABLE; INJECTION NONE MILES, INC 10GM/100ML; N160653 |
| DEXTRAN
40, 10% IN DEXTROSE 5% INJECTABLE; INJECTION NONE PHARMACHEM 10GM/100ML; N160836 |
DEXTRAN
40, 10% IN DEXTROSE 5% INJECTABLE; INJECTION RHEOMACRODEX PHARMALINK BASLAKEMEDEL AB 10GM/100ML; N140716 |
| DEXTRAN
40, 10% IN SODIUM CHLORIDE 0.9% INJECTABLE; INJECTION GENTRAN 40 BAXTER HEALTHCARE - IV SYSTEMS 10GM/100ML; N840620 |
DEXTRAN
40, 10% IN SODIUM CHLORIDE 0.9% INJECTABLE; INJECTION LMD IN PLASTIC CONTAINER ABBOTT LABS 10GM/100ML; ANDA |
| DEXTRAN
40, 10% IN SODIUM CHLORIDE 0.9% INJECTABLE; INJECTION RHEOMACRODEX PHARMALINK BASLAKEMEDEL AB 10GM/100ML; N140716 |
DEXTRAN
40, 10% IN SODIUM CHLORIDE 0.9% INJECTABLE; INJECTION NONE ABBOTT LABS 10GM/100ML; N160375 |
| DEXTRAN
40, 10% IN SODIUM CHLORIDE 0.9% INJECTABLE; INJECTION NONE MILES, INC 10GM/100ML; N160653 |
DEXTRAN
40, 10% IN SODIUM CHLORIDE 0.9% INJECTABLE; INJECTION NONE PHARMACHEM 10GM/100ML; N160836 |
| DEXTRAN
40, 10% IN SODIUM CHLORIDE 0.9% INJECTABLE; INJECTION NONE MCGAW, INC 10GM/100ML; N160767 |
DEXTRAN
70, 6% W/V DEXTRAN 70 IN 0.9% NACL IN 50 ML PVC BAGS INJECTABLE; INJECTION MACRODEX PHARMALINK BASLAKEMEDEL AB N830613 |
| DEXTRAN
70, 6% W/V DEXTRAN 70 IN 5% DEXTROSE INJECTABLE; INJECTION MACRODEX PHARMALINK BASLAKEMEDEL AB N830629 |
DEXTRAN
70, 6% IN DEXTROSE 5% INJECTABLE; INJECTION MACRODEX PHARMALINK BASLAKEMEDEL AB 6GM/100ML; N060826 |
| DEXTRAN
70, 6% IN SODIUM CHLORIDE 0.9% INJECTABLE; INJECTION MACRODEX PHARMALINK BASLAKEMEDEL AB 6GM/100ML; N060826 |
DEXTRAN
70, 6% IN SODIUM CHLORIDE 0.9% INJECTABLE; INJECTION NONE MCGAW, INC 6GM/100ML; N090024 |
| DEXTRAN
70, 6% IN SODIUM CHLORIDE 0.9% INJECTABLE; INJECTION NONE MILES, INC 6GM/100ML; N080716 |
DEXTRAN
70, 6% IN SODIUM CHLORIDE 0.9% INJECTABLE; INJECTION GENTRAN 70 BAXTER HEALTHCARE - IV SYSTEMS 6GM/100ML; N160607 |
| DEXTRAN
70, 6% IN DEXTROSE 5% INJECTABLE; INJECTION NONE ABBOTT LABS 6GM/100ML; N080819 |
DEXTRAN
75, 6% IN SODIUM CHLORIDE 0.9% INJECTABLE; INJECTION NONE PHARMACHEM 6GM/100ML; N080564 |
| DEXTRAN
75, 6% IN SODIUM CHLORIDE 0.9% INJECTABLE; INJECTION NONE PHARMACHEM 6GM/100ML; N160579 |
DEXTRAN
75, 6% IN SODIUM CHLORIDE 0.9% INJECTABLE; INJECTION NONE ABBOTT LABS 6GM/100ML; N18253 |
| HETASTARCH 6% IN
SODIUM CHLORIDE 0.9% NACL 500 ML GLASS BOTTLES INJECTABLE; INJECTION NONE ABBOTT LABORATORIES - HOSPITAL PRODUCTS DIV ANDA |
HETASTARCH 6% IN
SODIUM CHLORIDE 0.9% INJECTABLE; INJECTION HESPAN MCGAW, INC 6GM/100ML; N160889 |
| HETASTARCH
6% IN SODIUM CHLORIDE 0.9% INJECTABLE; INJECTION HESPAN IN PLASTIC CONTAINER MCGAW, INC 6GM/100ML; N890105 |
HETASTARCH
6% IN SODIUM CHLORIDE 0.9% INJECTABLE; INJECTION 6% HETASTARCH IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER ABBOTT 6GM/100ML; ANDA |
| HETASTARCH
6% IN 0.9% NACL INJECTABLE; INJECTION NONE GENSIA LABS, INC 6GM/100ML; ANDA |
HETASTARCH
6% IN 0.9% NACL INJECTABLE; INJECTION NONE MCGAW, INC 6GM/100ML; ANDA |
| HETASTARCH 6% IN
LACTATED ELECTROLYTE INJECTION INJECTABLE; INJECTION HEXTEND BIOTIME, INC 6GM/100ML N200952 |
INDIUM
IN111 CHLORIDE SOLUTION; INJECTION INDICLOR AMERSHAM N/A N19862 |
| INDIUM
IN111 CHLORIDE STERILE SOLUTION INJECTABLE; INJECTION ULTRAPURE MALLINCKRODT N/A N19841 |
PENTASTARCH 10%
IN SODIUM CHLORIDE 0.9% INJECTABLE; INJECTION PENTASPAN MCGAW, INC 10GM/100ML; N841207 |
| PENTASTARCH
10% IN SODIUM CHLORIDE 0.9% INJECTABLE; INJECTION PENTASPAN IN PLASTIC CONTAINER MCGAW, INC 10GM/100ML; N890104 |
PERFLUORODECALIN;
PERFLUOROTRI-N-PROPYLAMINE INJECTABLE; INJECTION FLUOSOL ALPHA THERPTC 17.5GM/100ML; N860909 |
| RED BLOOD CELL
PROCESSING SOLUTION INJECTABLE; INJECTION REJUVESOL CYTOSOL LABS, INC N950522 |
UROKINASE
INJECTABLE; INJECTION ABBOKINASE OPEN-CATHETER ABBOTT LABS 5,000 IU/VIAL N761021 |
| UROKINASE
INJECTABLE; INJECTION ABBOKINASE ABBOTT LABS 250,000 IU/VIAL N761021 |
UROKINASE
INJECTABLE; INJECTION ABBOKINASE ABBOTT LABS 9,000 IU/VIAL N761021 |
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