Approved NDA and ANDA Applications
Alphabetical Listing by Applicant Name
Information updated through August 31, 2008
BN761021 Abbott Laboratories - Pharmaceutical Products Division D-389, AP30 Pharmaceutical Products Division 200 Abbott Park Road Abbott Park, IL 60064-6157 Product Name: Urokinase Trade Name: Abbokinase Approved Date: 16-JAN-1978 BN860909 Alpha Therapeutic Corporation 5555 Valley Boulevard Los Angeles, CA 90032 Product Name: Perfluorochemical Emulsion Trade Name: Approved Date: 26-DEC-1989 BN19862 Amersham Health 2636 South Clearbrook Drive Arlington Heights, IL 60005 Product Name: Indium In-111 Chloride Sterile Solution Trade Name: Indiclor Approved Date: 29-DEC-1992 Approved Under Medi-Physics, Inc. BN090024 B. Braun Medical, Inc. 901 Macron Blvd Allentown, PA 18109 Product Name: Dextran 70 Trade Name: Approved Date: 18-AUG-1969 BN160767 B. Braun Medical, Inc. 901 Macron Blvd Allentown, PA 18109 Product Name: Dextran 40 Trade Name: Approved Date: 06-APR-1970 BN160889 B. Braun Medical, Inc. 901 Macron Blvd Allentown, PA 18109 Product Name: Hetastarch Trade Name: HESPAN 6% Hetastarch in 0.9% NaCl in Glass Bottles Approved Date: 17-JUL-1972 BN841207 B. Braun Medical, Inc. 901 Macron Blvd Allentown, PA 18109 Product Name: Pentastarch Trade Name: PENTASPAN 10% Pentastarch in 0.9% NaCl in 500mL Glass Bottl Approved Date: 19-MAY-1987 BN890104 B. Braun Medical, Inc. 901 Macron Blvd Allentown, PA 18109 Product Name: Pentastarch Trade Name: PENTASPAN (R) 10% Pentastarch in 0.9% NaCl in EXCEL Containers Approved Date: 04-APR-1991 Approved Under McGaw, Inc BN890105 B. Braun Medical, Inc. 901 Macron Blvd Allentown, PA 18109 Product Name: Hetastarch Trade Name: HESPAN (R) 6% Hetastarch in 0.9% NaCl, 250, 500, 1000 ml EXCEL Containers Approved Date: 04-APR-1991 Approved Under McGaw, Inc BA740283 B. Braun Medical, Inc. 901 Macron Blvd Allentown, PA 18109 Product Name: Hetastarch Trade Name: HESPAN (R) 6% Hetastarch in 0.9% NaCl in EXCEL Containers Approved Date: 21-OCT-1998 Approved Under McGaw, Inc BN160607 Baxter Healthcare Corporation 1620 Waukegan Road, MPGR-AL McGaw Park, IL 60085 Product Name: Dextran 70 Trade Name: GENTRAN 70 6% Dextran 70 and 0.9% NaCl in PL 146 Approved Date: 26-JAN-1970 Approved Under Baxter Healthcare Corporation - I.V. Systems Division BN840619 Baxter Healthcare Corporation Route 120 & Wilson Road Round Lake, IL 60073-0490 Product Name: Dextran 40 Trade Name: GENTRAN 40 10% Dextran 40 and 5% Dextrose Inj in PL 146 Approved Date: 22-FEB-1985 Approved Under Baxter Healthcare Corporation - I.V. Systems Division BN840620 Baxter Healthcare Corporation Route 120 & Wilson Road Round Lake, IL 60073-0490 Product Name: Dextran 40 Trade Name: GENTRAN 40 10% Dextran 40 and 0.9% NaCl Inj in PL 146 Approved Date: 22-FEB-1985 Approved Under Baxter Healthcare Corporation - I.V. Systems Division BN200952 BioTime, Inc. 1301 Harbor Bay Pkwy Alameda, CA 94502 Product Name: Hetastarch Trade Name: Hextend HMW Hydroxyethel Starch (6%) Approved Date: 31-MAR-1999 BN950522 Cytosol Laboratories, Inc. 55 Messina Drive Braintree, MA 02184-6783 Product Name: Rejuvesol Trade Name: Rejuvesol, CPD, ADSOL (AS-1) Approved Date: 26-FEB-1997 BN010409 Cytosol Laboratories, Inc. 55 Messina Drive Braintree, MA 02184-6783 Product Name: Anticoagulant Sodium Citrate Solution Trade Name: triCitrasol Anticoagulant Sodium Citrate Conc. 46.7% Trisodium Citrate, 30mL. Approved Date: 10-JUL-2003 BN020037 Cytosol Laboratories, Inc. 55 Messina Drive Braintree, MA 02184-6783 Product Name: Anticoagulant Citrate Dextrose Solution (ACD) Trade Name: Anticoagulant Citrate Dextrose Solution, Solution, U.S.P., (ACD- A). 50 mL, PN 6053 Approved Date: 26-AUG-2003 BN100855 Fenwal Inc 25212 W. Illinois Route 120, RLP-34 Round Lake, IL 60073 Product Name: Anticoagulant Citrate Dextrose Solution (ACD) Trade Name: Approved Date: 03-JUN-1959 Approved Under Baxter Healthcare Corporation BN160918 Fenwal Inc 25212 W. Illinois Route 120, RLP-34 Round Lake, IL 60073 Product Name: Anticoagulant Citrate Dextrose Solution (ACD) Trade Name: ACD BLOOD PACK UNITS, USP, in PL 146 Plastic 450mL bags; 500mL and 1000mL bulk Approved Date: 17-MAR-1978 Approved Under Baxter Healthcare Corporation BN770420 Fenwal Inc 25212 W. Illinois Route 120, RLP-34 Round Lake, IL 60073 Product Name: Anticoagulant Citrate Phosphate Dextrose Adenine Solution (CPDA) Trade Name: CPDA-1 BLOOD-PACK Unit, (PL 146 Plastic) 250, 450, 500 mL Blood Pack Units Approved Date: 12-MAY-1978 Approved Under Baxter Healthcare Corporation BN770923 Fenwal Inc 25212 W. Illinois Route 120, RLP-34 Round Lake, IL 60073 Product Name: Anticoagulant Sodium Citrate Solution Trade Name: Sodium Citrate Blood Pack Units, (PL 146 Plastic) 250 mL and 500 mL bulk units Approved Date: 20-JAN-1978 Approved Under Baxter Healthcare Corporation BN900224 Fenwal Inc 25212 W. Illinois Route 120, RLP-34 Round Lake, IL 60073 Product Name: Anticoagulant Citrate Phosphate Dextrose Solution (CPD) Trade Name: CPD Anticoagulant in PL 2209 Plastic Approved Date: 27-DEC-1991 Approved Under Baxter Healthcare Corporation BN090480 Fenwal Inc 25212 W. Illinois Route 120, RLP-34 Round Lake, IL 60073 Product Name: Anticoagulant Ethylenediamine tetraacetic Acid (EDTA) Trade Name: Approved Date: 07-MAR-1955 Approved Under Baxter Healthcare Corporation BN170401 Fenwal Inc 25212 W. Illinois Route 120, RLP-34 Round Lake, IL 60073 Product Name: Anticoagulant Citrate Phosphate Dextrose Solution (CPD) Trade Name: CPD BLOOD-PACK Unit, (PL 146 Plastic) 500mL bulk, 450 mL bag, ... Approved Date: 06-DEC-1977 Approved Under Baxter Healthcare Corporation BN811012 Fenwal Inc 25212 W. Illinois Route 120, RLP-34 Round Lake, IL 60073 Product Name: Anticoagulant Citrate Phosphate Dextrose Solution (CPD) Trade Name: CPD BLOOD-PACK Unit, (PL 1240 Plastic) Approved Date: 28-JUN-1983 Approved Under Baxter Healthcare Corporation BN811104 Fenwal Inc 25212 W. Illinois Route 120, RLP-34 Round Lake, IL 60073 Product Name: Anticoagulant Citrate Phosphate Dextrose Solution (CPD) Trade Name: CPD, ADSOL Red Cell Preservation Solution,(PL 146) and/or SEPACELL Filter Approved Date: 16-MAY-1983 Approved Under Baxter Healthcare Corporation BN900223 Fenwal Inc 25212 W. Illinois Route 120, RLP-34 Round Lake, IL 60073 Product Name: Anticoagulant Citrate Phosphate Dextrose Solution (CPD) Trade Name: ADSOL Red Cell Preservation Solution (PL 2209) CPD and ADSOL and/or SEPACELL in PL 2209 Approved Date: 27-DEC-1991 Approved Under Baxter Healthcare Corporation BN940404 Fenwal Inc 25212 W. Illinois Route 120, RLP-34 Round Lake, IL 60073 Product Name: Anticoagulant Citrate Phosphate Dextrose Adenine Solution (CPDA) Trade Name: CPDA-1 BLOOD PACK UNIT in PL 2209 Approved Date: 28-JUL-1994 Approved Under Baxter Healthcare Corporation BN000922 Fenwal Inc 25212 W. Illinois Route 120, RLP-34 Round Lake, IL 60073 Product Name: Anticoagulant Citrate Dextrose Solution (ACD) Trade Name: Adsol with ACD-A Approved Date: 29-AUG-2002 Approved Under Baxter Healthcare Corporation BN070012 Fresenius Kabi Deutschland GmbH Else Kroner Strasse 1 61352 Bad Homburg v.d.H. , Germany Product Name: 6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection Trade Name: Voluven Approved Date: 27-DEC-2007 Approved Under Fresnius Kabi BN160702 Fresenius USA, Inc. 2637 Shadelands Drive Walnut Creek, CA 94598 Product Name: Anticoagulant Sodium Citrate Solution Trade Name: Approved Date: 28-DEC-1970 BN110912 Fresenius USA, Inc. 2637 Shadelands Drive Walnut Creek, CA 94598 Product Name: Anticoagulant Citrate Dextrose Solution (ACD) Trade Name: Approved Date: 02-SEP-1959 BN160907 Fresenius USA, Inc. 2637 Shadelands Drive Walnut Creek, CA 94598 Product Name: Anticoagulant Citrate Phosphate Dextrose Solution (CPD) Trade Name: Approved Date: 16-MAY-1973 BN770822 Fresenius USA, Inc. 2637 Shadelands Drive Walnut Creek, CA 94598 Product Name: Anticoagulant Heparin Trade Name: Approved Date: 17-MAY-1978 BN780519 Fresenius USA, Inc. 2637 Shadelands Drive Walnut Creek, CA 94598 Product Name: Anticoagulant Citrate Phosphate Dextrose Solution (CPD) Trade Name: Approved Date: 23-APR-1980 BA010228 Gambro BCT, Inc 10811 W. Collins Ave. Lakewood, CO 80215 Product Name: Anticoagulant Citrate Dextrose Solution (ACD) Trade Name: ACD-A Solution Approved Date: 25-FEB-2002 BN001214 Gambro BCT, Inc 10811 W. Collins Ave. Lakewood, CO 80215 Product Name: Anticoagulant Citrate Dextrose Solution (ACD) Trade Name: AS3 Solution/ACD-A Approved Date: 29-MAY-2002 BA980728 Haemonetics Corporation 400 Wood Road Braintree, MA 02184 Product Name: Anticoagulant Citrate Dextrose Solution (ACD) Trade Name: Anticoagulant Citrate Dextrose Solution Formula A Approved Date: 06-FEB-2002 BN000127 Haemonetics Corporation 400 Wood Road Braintree, MA 02184 Product Name: Anticoagulant Citrate Phosphate 2X Dextrose Solution (CP2D) Trade Name: Citrate Phosphate Double Dextrose/Additive Soln 3 Approved Date: 18-JAN-2002 BN980123 Haemonetics Corporation 400 Wood Road Braintree, MA 02184 Product Name: Anticoagulant Sodium Citrate Solution Trade Name: Anticoagulant Sodium Citrate, 4% w/v Solution U.S. Approved Date: 03-MAR-2000 BN080819 Hospira, Inc. 275 N. Field Drive D-389, H2 Lake Forest, IL 60045-3537 Product Name: Dextran 70 Trade Name: 6% Dextran 70 and 0.9% NaCl or/ 5% Dextrose 500 mL Glass Bottle Approved Date: 31-MAR-1953 BN160375 Hospira, Inc. 275 N. Field Drive D-389, H2 Lake Forest, IL 60045-3537 Product Name: Dextran 40 Trade Name: 10% LMD w/v Dextran 40 in 5% Dextrose or/ 0.9%NaCl Approved Date: 25-JUL-1967 BA720562 Hospira, Inc. 275 N. Field Drive D-389, H2 Lake Forest, IL 60045-3537 Product Name: Dextran 40 Trade Name: 500 mL Flexible Containers Approved Date: 30-OCT-1992 Approved Under Abbott Laboratories - Hospital Products Division. BA720563 Hospira, Inc. 275 N. Field Drive D-389, H2 Lake Forest, IL 60045-3537 Product Name: Dextran 40 Trade Name: 10% Low Molecular Weight Dextrose (LMD) in 5% Dextrose Approved Date: 30-OCT-1992 Approved Under Abbott Laboratories - Hospital Products Division. BA720746 Hospira, Inc. 275 N. Field Drive D-389, H2 Lake Forest, IL 60045-3537 Product Name: Hetastarch Trade Name: 500 mL Glass Bottles Approved Date: 07-FEB-1996 Approved Under Abbott Laboratories - Hospital Products Division. BA740193 Hospira, Inc. 275 N. Field Drive D-389, H2 Lake Forest, IL 60045-3537 Product Name: Hetastarch Trade Name: 6% Hetastarch in 0.9% NaCl 500 mL in PVC Plastic Approved Date: 30-JAN-1995 Approved Under Abbott Laboratories - Hospital Products Division. BN040083 MacoProductions S.A.S. c/o Hoppe Regulatory Consultants 2335 massey Lane Decatur, GA 30033 Product Name: Anticoagulant Citrate Phosphate Dextrose Solution (CPD) Trade Name: MacoProductions S.A.S. CPD/AS-1: MacoPharma Leucoflex MTL1 Leukoreduction System for Blood Components known as MTL1-WB Approved Date: 21-NOV-2005 BN19841 Mallinckrodt Medical, Inc. 675 McDonnell Boulevard St. Louis, MO 63134 Product Name: Indium In-111 Chloride Sterile Solution Trade Name: Indium In-111 Chloride Sterile Solution Approved Date: 27-SEP-1994 BN060826 Meda AB Kanalvagen 18 P.O.Box 625 SE-194 26 Upplands Vasby, Sweden Product Name: Dextran 70 Trade Name: MACRODEX 6% w/v Dextran 70 in 0.9% NaCl or/ 5% Dextrose Approved Date: 08-JUN-1954 BN140716 Meda AB Kanalvagen 18 P.O.Box 625 SE-194 26 Upplands Vasby, Sweden Product Name: Dextran 40 Trade Name: RHEOMACRODEX 10% w/v Dextran 40 in 0.9% NaCl or/ 5% Dextrose Approved Date: 18-JAN-1967 BN830527 Meda AB Kanalvagen 18 P.O.Box 625 SE-194 26 Upplands Vasby, Sweden Product Name: Dextran 40 Trade Name: RHEOMACRODEX 10% w/v Dextran 40 in 0.9% NaCl 500 mL PVC Bags Approved Date: 27-MAR-1985 BN830613 Meda AB Kanalvagen 18 P.O.Box 625 SE-194 26 Upplands Vasby, Sweden Product Name: Dextran 70 Trade Name: MACRODEX 6% w/v Dextran 70 in 0.9% NaCl in 500 mL PVC Bags Approved Date: 27-MAR-1985 BN830627 Meda AB Kanalvagen 18 P.O.Box 625 SE-194 26 Upplands Vasby, Sweden Product Name: Dextran 40 Trade Name: RHEOMACRODEX 10% w/v Dextran 40 in 5% Dextrose 500 mL PVC Bags Approved Date: 27-MAR-1985 BN830629 Meda AB Kanalvagen 18 P.O.Box 625 SE-194 26 Upplands Vasby, Sweden Product Name: Dextran 70 Trade Name: MACRODEX 6% w/v Dextran 70 in 5% Dextrose Approved Date: 27-MAR-1985 BN830715 Meda AB Kanalvagen 18 P.O.Box 625 SE-194 26 Upplands Vasby, Sweden Product Name: Dextran 1 Trade Name: PROMIT Approved Date: 30-OCT-1984 BN760305 Medsep Corporation 1630 Industrial Park Street Covina, CA 91722 Product Name: Anticoagulant Sodium Citrate Solution Trade Name: Anticoagulant 4% Sodium Citrate Solution Approved Date: 30-JUN-1978 BN800077 Medsep Corporation 1630 Industrial Park Street Covina, CA 91722 Product Name: Anticoagulant Citrate Phosphate Dextrose Adenine Solution (CPDA) Trade Name: CPDA-1 Approved Date: 06-NOV-1980 BN800222 Medsep Corporation 1630 Industrial Park Street Covina, CA 91722 Product Name: Anticoagulant Citrate Phosphate Dextrose Solution (CPD) Trade Name: Approved Date: 23-AUG-1982 BN820915 Medsep Corporation 1630 Industrial Park Street Covina, CA 91722 Product Name: Anticoagulant Citrate Phosphate 2X Dextrose Solution (CP2D) Trade Name: CP2D and AS-3 Nutricel Approved Date: 22-SEP-1983 BN080716 Miles, Inc. 4th and Parker Streets, P.O. Box 1986 Berkeley, CA 94701-1986 Product Name: Dextran 70 Trade Name: Approved Date: 13-MAR-1953 BN100102 Miles, Inc. 4th and Parker Streets, P.O. Box 1986 Berkeley, CA 94701-1986 Product Name: Anticoagulant Citrate Dextrose Solution (ACD) Trade Name: Approved Date: 14-DEC-1961 BN160527 Miles, Inc. 4th and Parker Streets, P.O. Box 1986 Berkeley, CA 94701-1986 Product Name: Anticoagulant Citrate Phosphate Dextrose Solution (CPD) Trade Name: Approved Date: 22-JUN-1970 BN160653 Miles, Inc. 4th and Parker Streets, P.O. Box 1986 Berkeley, CA 94701-1986 Product Name: Dextran 40 Trade Name: Approved Date: 23-SEP-1969 BN080564 Pharmachem Corporation P.O. Box 1035 Bethlehem, PA 18016-1035 Product Name: Dextran 75 Trade Name: 6% Dextran 75 Inj in 0.9% NaCl Approved Date: 19-SEP-1952 BN160759 Pharmachem Corporation P.O. Box 1035 Bethlehem, PA 18016-1035 Product Name: Dextran 75 Trade Name: 6% Dextran 75 in 0.9% NaCl in Polyethylene Contain Approved Date: 19-AUG-1970 BN160836 Pharmachem Corporation P.O. Box 1035 Bethlehem, PA 18016-1035 Product Name: Dextran 40 Trade Name: LMWD 10% (Dextran 40) in 0.9% NaCl or 5% Dextrose Approved Date: 14-NOV-1972 BN781211 Terumo Medical Corporation 125 Blue Ball Road Elkton, MD 21921 Product Name: Anticoagulant Citrate Phosphate Dextrose Solution (CPD) Trade Name: Anticoagulant Citrate Phosphate Dextrose (CPD) Solution in TERUFLEX Blood Bag System Approved Date: 10-JUN-1981 BN781214 Terumo Medical Corporation 125 Blue Ball Road Elkton, MD 21921 Product Name: Anticoagulant Sodium Citrate Solution Trade Name: Anticoagulant 4% Sodium Citrate Solution in TERUFLEX Blood Bag System Approved Date: 08-FEB-1980 BN820528 Terumo Medical Corporation 125 Blue Ball Road Elkton, MD 21921 Product Name: Anticoagulant Citrate Phosphate Dextrose Adenine Solution (CPDA) Trade Name: Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) Solution in TERUFLEX Blood Bag System Approved Date: 03-NOV-1982 BN880217 Terumo Medical Corporation 125 Blue Ball Road Elkton, MD 21921 Product Name: Anticoagulant Citrate Phosphate Dextrose Solution (CPD) Trade Name: (OPTISOL) Anticoagulant Citrate Phosphate Dextrose (CPD) Solution with OPTISOL Red Cell Preservative Solution in TERUFLEX (or IMUFLEX) Blood Bag Syste Approved Date: 07-OCT-1988 BA740592 Teva Parenteral Medicines, Inc. 19 Hughes Irvine, CA 92718-1902 Product Name: Hetastarch Trade Name: 6% Hetastarch in 0.9% NaCl in 500mL Plastic Bags Approved Date: 12-NOV-1998 Approved Under Gensia Laboratories, Ltd