Approved NDA and ANDA Applications

Alphabetical Listing by Applicant Name

Information updated through December 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-0389, Bldg. H2-2
               Lake Forest, IL 60045-5046
           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-0389, Bldg. H2-2
               Lake Forest, IL 60045-5046
           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-0389, Bldg. H2-2
               Lake Forest, IL 60045-5046
           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-0389, Bldg. H2-2
               Lake Forest, IL 60045-5046
           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-0389, Bldg. H2-2
               Lake Forest, IL 60045-5046
           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-0389, Bldg. H2-2
               Lake Forest, IL 60045-5046
           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
 
Updated: January 8, 2009