Approved NDA and ANDA Applications
Alphabetical Listing by Applicant Name
Information updated through March 31, 2009
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 Medical Care North America
920 Winter Street
Waltham, WA 02451
Product Name: Anticoagulant Sodium Citrate
Solution
Trade Name:
Approved Date: 28-DEC-1970
Approved Under Fresenius USA, Inc.
BN110912 Fresenius Medical Care North America
920 Winter Street
Waltham, WA 02451
Product Name: Anticoagulant Citrate Dextrose
Solution (ACD)
Trade Name:
Approved Date: 02-SEP-1959
Approved Under Fresenius USA, Inc.
BN160907 Fresenius Medical Care North America
920 Winter Street
Waltham, WA 02451
Product Name: Anticoagulant Citrate Phosphate
Dextrose Solution (CPD)
Trade Name:
Approved Date: 16-MAY-1973
Approved Under Fresenius USA, Inc.
BN770822 Fresenius Medical Care North America
920 Winter Street
Waltham, WA 02451
Product Name: Anticoagulant Heparin
Trade Name:
Approved Date: 17-MAY-1978
Approved Under Fresenius USA, Inc.
BN780519 Fresenius Medical Care North America
920 Winter Street
Waltham, WA 02451
Product Name: Anticoagulant Citrate Phosphate
Dextrose Solution (CPD)
Trade Name:
Approved Date: 23-APR-1980
Approved Under Fresenius USA, Inc.
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
BA070025 Gambro BCT, Inc
10811 W. Collins Ave.
Lakewood, CO 80215-4498
Product Name: Anticoagulant Citrate Phosphate
Dextrose Solution (CPD)
Trade Name: GAMBRO BCT
Approved Date: 06-JAN-2009
BA980728 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184-9114
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 02184-9114
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 02184-9114
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