Prescription Drug User Fee Act
User Fee Billable Products Approved Under Section 351 of the PHS Act
This list is intended to include all CBER user fee billable biologic products and potencies approved under Section 351 of the Public Health Service Act**.
A product fee is assessed for each potency in which the approved (non-revoked, non-suspended) product is manufactured in final dosage form. In certain circumstances, products which have been discontinued from marketing but are still licensed are not assessed product fees. These products are identified on CBER's Discontinued List. Generally, a licensed product is added to the Discontinued List when the Applicant informs CBER's user fee staff that the product is no longer marketed. Products may also be added if annual reports indicate the product is no longer marketed.
The potency information contained in this list is based on current information in CBER's regulatory database. Companies are responsible for alerting CBER to any discrepancies regarding potency or proprietary name information. Any such discrepancies should be reported to CBER's user fee billing staff at 301-827-3503.
This list is updated bi-annually in September and March.
**A number of therapeutic biologic products were transferred from CBER to the Center for Drug Evaluation and Research (CDER) on June 30, 2003. The transferred biologics, approved under Section 351, are listed on the CDER website. On the CDER page, click on ‘Reports and Other Documents’, then on ‘Prescription Drug User Fee Act (PDUFA) CDER Billable Biologic Products.
| Applicant/ License No. |
Proprietary Name / Proper Name |
BLA STN | BLA Approval Date | Billable Potencies |
|---|---|---|---|---|
| ALK-Abello, Inc License 1256 |
Histatrol Positive Skin Test Control - Histamine |
103754/0 | 2/23/1998 | 0.1 mg/mL 1 mg/mL |
| Acambis, Inc License 1733 |
ACAM2000 Smallpox (Vaccinia) Vaccine, Live |
125158/0 | 8/31/2007 | 1 – 5 x 108 PFU/mL |
| Baxter Healthcare Corp License 0140 |
Buminate Albumin (Human) |
101452/0 | 3/3/1954 | 5% 20% 25% |
| Aralast Alpha-1 Proteinase Inhibitor (Human) |
125039/0 | 12/23/2002 | 0.5 g/vial 1 g/vial |
|
| Feiba VH Anti-Inhibitor Coagulant Complex |
101447/0 | 12/21/1979 | 500 u/vial 1000 u/vial 2500 u/vial |
|
| Hemofil M Antihemophilic Factor (Human) |
101448/0 | 3/11/1966 | 250 IU/vial 500 IU/vial 1000 IU/vial 1700 IU/vial |
|
| Advate Antihemophilic Factor (Recombinant) Plasma/Albumin Free Method |
125063/0 | 7/25/2003 | 250 IU/vial 500 IU/vial 1,000 IU/vial 1,500 IU/vial 2,000 IU/vial 3,000 IU/vial |
|
| Recombinate Antihemophilic Factor (Recombinant) |
103375/0 | 12/10/1992 | 250 IU/vial 500 IU/vial 1,000 IU/vial |
|
| Bebulin VH Factor IX Complex |
103112/0 | 8/21/1970 | 200-1200 u – 20mL vial | |
| Tisseel Fibrin Sealant |
103980/0 | 2/7/2000 | 2 mL (lyophilized) 4 mL(lyophilized) 10 mL(lyophilized) |
|
| Tisseel Fibrin Sealant |
103980/5121 | 7/27/2006 | 3,000 KIU/500 IU/mL (frozen solution in 2, 4, and 10 mL prefilled syringes) | |
Artiss |
125266/0 | 3/19/2008 | 2 mL kit (lyophilized) |
|
| Artiss Fibrin Sealant (Human) |
125266/0 | 3/19/2008 | 3,000 KIU/4 IU/mL (frozen solution in 2, 4, and 10 mL prefilled syringes) | |
| Gammagard Liquid Immune Globulin Intravenous (Human) 10% Solution |
125105/0 | 4/27/2005 | 10% (100 mg/mL) | |
| Gammagard S/D Immune Globulin Intravenous (Human) |
103133/0 | 2/18/1986 | 0.5 g/vial 2.5 g/vial 5.0 g/vial 10 g/vial |
|
| Protenate Plasma Protein Fraction (Human) |
101454/0 | 6/16/1960 | 5% | |
| Ceprotin Protein C Concentrate (Human) |
125234/0 | 3/30/2007 | 500 IU/vial 1,000 IU/vial |
|
| Bayer Corp License 0008 |
Kogenate FS Antihemophilic Factor (Recombinant) |
103332/0 | 2/25/1993 | 250 IU/vial 500 IU/vial 1,000 IU/vial 2,000 IU/vial |
| Berna Biotech Ltd License 1632 |
Vivotif Typhoid Vaccine Live Oral Ty21a |
103123/0 | 12/15/1989 | 2-6.8 bil cfu/capsule |
| Biotest Pharmaceuticals Corp License 1792 |
Nabi-HB Hepatitis B Immune Globulin (Human) |
103945/0 | 10/23/2001 | >312 IU/mL |
| California Department of Health Services License 1622 |
Baby BIG Botulism Immune Globulin Intravenous (Human) |
125034/0 | 10/23/2003 | 100 mg/vial |
| Cangene Corp License 1201 |
Doxamune B HepaGamB Hepatitis B Immune Globulin (Human) |
125035/0 | 1/27/2006 | >312 IU/mL |
| HepaGam B Hepatitis B Immune Globulin Intravenous (Human) |
125237/0 | 4/6/2007 | >312 IU/mL | |
| WinRho SDF Liquid Rho(D) Immune Globulin Intravenous (Human) |
103649/5107 | 3/31/2005 | 1,400 IU/mL | |
| CNJ-016 Vaccinia Immune Globulin Intravenous (Human) |
125109/0 | 5/2/2005 | >50,000 u/15mL | |
| CSL Behring AG License 1766 |
AlbuRx Albumin (Human) |
102366/0 | 7/23/1976 | 5% 25% |
| Cytogam Cytomegalovirus Immune Globulin Intravenous (Human) |
103189/0 | 4/17/1990 | 5% | |
| Carimune NF, Panglobulin, Sandoglobulin Immune Globulin Intravenous (Human) |
102367/0 | 6/7/1984 | 3 g/vial 6 g/vial 12 g/vial |
|
| Privigen Immune Globulin Intravenous (Human), 10% Liquid |
125201/0 | 7/26/2007 | 10% (5 g/50 mL, 10 g/100 mL, and 20 g/200 mL vials) | |
| Rhophylac Rho(D) Immune Globulin Intravenous (Human) |
125070/0 | 2/12/2004 | 1,500 IU/syringe | |
| CSL Behring GmbH License 1765 |
Humate-P Antihemophilic Factor / von Willebrand Factor Complex (Human) |
103960/0 | 4/11/2000 | 250 IU/vial 500 IU/vial 1,000 IU/vial |
| Vivaglobin Immune Globulin Subcutaneous (Human) |
125115/0 | 1/9/2006 | 160 mg IgG/mL | |
| CSL Behring LLC License 1767 |
Albuminar Albumin (Human) |
103955/0 | 3/17/2000 | 5% 20% 25% |
| Zemaira Alpha-1-Proteinase Inhibitor (Human) |
125078/0 | 7/8/2003 | 1.0 g/vial | |
| Monoclate-P Antihemophilic Factor (Human) |
103953/0 | 3/17/2000 | 250 IU/vial 500 IU/vial 1000 IU/vial 1500 IU/vial |
|
| Mononine Coagulation Factor IX (Human) |
103957/0 | 3/17/2000 | 500 IU/vial 1000 IU/vial |
|
| Gammar-P I.V. Immune Globulin Intravenous (Human) |
103956/0 | 3/17/2000 | 10 g/vial | |
| CSL Limited License 1764 |
Afluria Influenza Virus Vaccine |
125254/0 | 9/28/2007 | 0.5 mL/dose |
| Emergent BioDefense Operations Lansing, Inc. License 1755 |
Biothrax Anthrax Vaccine Adsorbed |
103821/0 | 11/12/1998 | 0.5 mL/vial |
| Genzyme Biosurgery License 1659 |
Carticel SM Service Autologous Cultured Chondrocytes |
103661/0 | 8/22/1997 | 12 mil/vial |
| Genzyme Corp License 1596 |
Thymoglobulin Anti-thymocyte Globulin (Rabbit) |
103869/0 | 5/19/1999 | 25 mg/vial |
| GlaxoSmithKline Biologicals License 1617 |
Infanrix Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed |
103647/0 | 1/29/1997 | 25Lf/10Lf/25mcg/0.5mL |
| Kinrix Diphtheria and Tetanus Toxoids, Acellular Pertussis Vaccine Adsorbed and Poliovirus Vaccine Inactivated Combined |
125260/0 | 6/24/2008 | 0.5 mL/vial | |
| Pediarix DTaP & Hepatitis B (Recombinant) & Inactivated Polio Virus Vaccine |
103907/0 | 12/13/2002 | 0.5 mL/vial | |
| Twinrix Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine |
103850/0 | 5/11/2001 | 1 mL/vial | |
| Havrix Hepatitis A Vaccine Inactivated |
103475/0 | 2/22/1995 | 1440 ELISA u/mL | |
| Engerix-B Hepatitis B Vaccine (Recombinant) |
103239/0 | 8/28/1989 | 10 mcg/0.5 mL vial | |
| Fluarix Influenza Virus Vaccine |
125127/0 | 8/31/2005 | 45 mcg/0.5 mL | |
| Rotarix Rotavirus Vaccine, Live, Oral, Monovalent |
125265/0 | 4/3/2008 | 1 mL/dose | |
| Boostrix Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed |
125106/0 | 5/3/2005 | 2.5Lf/5Lf/2.5mcg/8mcg/0.5mL | |
| Grifols Biologicals, Inc License 1694 |
Albutein Albumin (Human) |
102478/0 | 8/15/1978 | 5% 20% 25% |
| Alphanate Antihemophilic Factor/Von Willebrand Factor Complex (Human) |
102475/0 | 8/15/1978 | 250 IU/vial 500 IU/vial 1000 IU/vial 1500 IU/vial |
|
| AlphaNine SD Coagulation Factor IX (Human) |
103249/0 | 12/31/1990 | 500 IU/vial 1000 IU/vial 1500 IU/vial |
|
| Profilnine SD Factor IX Complex |
102476/0 | 7/20/1981 | 500 IU/vial 1000 IU/vial 1500 IU/vial |
|
| Hollister-Stier Laboratories LLC License 1272 |
Positive Skin Test Control-Histamine | 103891/0 | 6/2/1999 | 6 mg/mL |
| ID Biomedical Corp of Quebec License 1739 |
FluLaval Influenza Virus Vaccine |
125163/0 | 10/5/2006 | 15 mcg/0.5 mL vial |
| Instituto Grifols, SA License 1181 |
Albumin (Human) | 103352/0 | 2/17/1995 | 20% 25% |
| Flebogamma Immune Globulin Intravenous (Human) |
125077/0 | 12/15/2003 | 5% | |
| JHP Pharmaceuticals LLC License 1781 |
Aplisol Tuberculin, Purified Protein Derivative |
103782/0 | 4/20/1998 | 5 TU/mL |
| MassBioLogics License 1779 |
Tetanus and Diphtheria Toxoids Adsorbed For Adult Use | 101322/0 | 7/27/1970 | 0.5 mL/vial |
| MedImmune Vaccines Inc. (a wholly owned subsidiary of MedImmune, Inc.) License 1652 |
Flumist Influenza Virus Vaccine Live, Intranasal |
125020/0 | 6/17/2003 | 0.2 mL spray |
| Merck & Co., Inc License 0002 |
Antivenin (Latrodectus mactans) | 101062/0 | 2/13/1936 | nlt 6000 u/vial |
| COMVAX Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine |
103623/0 | 10/2/1996 | 7.5 mcg PRP/125 mcg OMPC/5 mcg HBsAg/0.5mL vial | |
| PedvaxHIB Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) |
103237/0 | 12/20/1989 | 7.5 mcg/0.5mL | |
| VAQTA Hepatitis A Vaccine Inactivated |
103606/0 | 3/29/1996 | 50 u/mL | |
| Recombivax, Recombivax HB Hepatitis B Vaccine (Recombinant) |
101066/0 | 7/23/1986 | 10 mcg/mL 40 mcg/mL |
|
| GARDASIL Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine |
125126/0 | 6/8/2006 | 0.5 mL/syringe | |
| Attenuvax Measles Virus Vaccine Live |
101068/0 | 3/21/1963 | nlt 1000 u/0.5 mL vial | |
| M-M-R II Measles, Mumps and Rubella Virus Vaccine Live |
101069/0 | 4/22/1971 | 0.5 mL/vial | |
| ProQuad Measles, Mumps, Rubella and Varicella Virus Vaccine Live |
125108/0 | 9/6/2005 | 0.5 mL/vial | |
| MumpsVax Mumps Virus Vaccine Live |
101072/0 | 12/28/1967 | 0.5 mL/vial | |
| Normal Horse Serum | 101084/0 | 1/2/1959 | ||
| Pneumovax 23 Pneumococcal Vaccine, Polyvalent |
101094/0 | 11/21/1977 | 25 mcg/0.5 mL vial | |
| RotaTeq Rotavirus Vaccine, Live, Oral Pentavalent |
125122/0 | 2/3/2006 | 2 mL/tube | |
| Meruvax II Rubella Virus Vaccine Live |
101075/0 | 6/9/1969 | nlt 1000 u/0.5 mL vial | |
| Varivax Varicella Virus Vaccine Live |
103552/0 | 3/17/1995 | nlt 1350 pf u/0.5mL | |
| Zostavax Zoster Vaccine Live |
125123/0 | 5/25/2006 | 0.65 mL/vial | |
| Novartis Vaccines and Diagnostics GmbH & Co. KG License 1754 |
RabAvert Rabies Vaccine |
103334/0 | 10/20/1997 | 2.5 u/vial |
| Novartis Vaccines and Diagnostics Limited License 1750 |
FluVirin Influenza Virus Vaccine |
103837/0 | 11/3/1998 | 15 mcg/0.5 mL |
| Novo Nordisk A/S License 1261 |
NovoSeven, NovoSeven RT Coagulation Factor VIIa (Recombinant) |
103665/0 | 3/25/1999 | 1.0 mg/vial |
| Octapharma Pharmazeutika Produktionsges.m.b.H. License 1646 |
Albumin (Human) | 125154/0 | 10/17/2006 | 5% 20% 25% |
| Octagam Immune Globulin Intravenous (Human) |
125062/0 | 5/21/2004 | 5% | |
| OMRIX biopharmaceuticals, Ltd License 1603 |
Evicel Fibrin Sealant (Human) |
125010/0 | 3/21/2003 | 1 mL kit 2 mL kit 5 mL kit |
Evithrom Thrombin, Topical (Human) |
125247/0 | 8/27/2007 | 800-1,200 IU/mL |
| Organon Teknika Corp License 0956 |
Tice BCG BCG Live |
102821/0 | 6/21/1989 | 100-800 mil cfu/vial |
| BCG Vaccine | 103050/0 | 6/21/1989 | 100-800 mil cfu/vial | |
| Ortho-Clinical Diagnostics, Inc License 1236 |
RhoGAM Rho(D) Immune Globulin (Human) |
103777/0 | 4/23/1998 | 50 mcg 300 mcg |
| Ovation Pharmaceuticals, Inc License 1688 |
Panhematin Hemin for Injection |
101246/0 | 7/20/1983 | 313 mg/vial |
| Pharmacia & Upjohn Company License 1216 |
Atgam Lymphocyte Immune Globulin, Anti-thymocyte Globulin (Equine) |
103676/0 | 12/4/1996 | 50 mg/mL |
| Protherics Inc, a wholly-owned subsidiary of Protherics PLC License 1575 |
CroFab Crotalidae Polyvalent Immune Fab (Ovine) |
103788/0 | 10/2/2000 | 1 g/vial |
| DigiFab Digoxin Immune Fab (Ovine) |
103910/0 | 8/31/2001 | 40 mg/vial | |
| Research Foundation for Microbial Diseases of Osaka University (The) License 1156 |
JE-Vax Japanese Encephalitis Virus Vaccine Inactivated |
103376/0 | 12/10/1992 | 1.0 mL/vial |
| Sanofi Pasteur, Inc License 1725 |
Tripedia Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed |
103922/0 | 12/9/1999 | 6.7Lf/5Lf/46.8 mcg/0.5mL |
| Diphtheria & Tetanus Toxoids Adsorbed | 103919/0 | 12/9/1999 | 6.6; 5 UNT;UNT | |
| Fluzone Influenza Virus Vaccine |
103914/0 | 12/9/1999 | 45 mcg/0.5mL | |
| Influenza Virus Vaccine, H5N1 | 125244/0 | 4/17/2007 | 90 mcg/mL | |
| Menactra Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine |
125089/0 | 1/14/2005 | 48 mcg/0.5mL | |
| Menomune - A/C Meningococcal Polysaccharide Vaccine, Groups A and C Combined |
103925/0 | 12/9/1999 | 50 mcg/0.5mL | |
| Menomune - A/C/Y/W-135 Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined |
103926/0 | 12/9/1999 | 50 mcg/0.5mL | |
| Tetanus Toxoid Adsorbed | 103913/0 | 12/9/1999 | 5Lf/0.5mL | |
| DECAVAC Tetanus & Diphtheria Toxoids Adsorbed For Adult Use |
103921/0 | 12/9/1999 | 5Lf/2Lf/0.5mL | |
| YF-Vax Yellow Fever Vaccine |
103915/0 | 12/9/1999 | 4.74 pfu/0.5mL | |
| Sanofi Pasteur Limited License 1726 |
TheraCys BCG Live |
103943/0 | 2/24/2000 | 81 mg/vial |
| Mycobax BCG Vaccine |
103942/0 | 2/24/2000 | 1.5 mg/vial, multidose | |
| Botulism Antitoxin | 103937/0 | 2/24/2000 | 5,000 IU/vial | |
| Daptacel Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed |
103666/0 | 5/14/2002 | 15 Lf/5 Lf/PT 10 mcg/FHA 5 mcg/PRN 3 mcg/FIM 5 mcg/0.5mL | |
| Diphtheria & Tetanus Toxoids Adsorbed | 103944/0 | 2/24/2000 | 25Lf/5Lf/0.5mL | |
Pentacel |
125145/0 | 6/20/2008 | 0.5 mL/vial | |
| Poliovax Poliovirus Vaccine Inactivated (Human Diploid Cell) |
103940/0 | 2/24/2000 | 0.5 mL/vial | |
| Tetanus and Diphtheria Toxoids Adsorbed for Adult Use | 103171/0 | 11/3/2003 | 5 Lf/2 Lf/0.5mL | |
| Adacel Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed |
125111/0 | 6/10/2005 | T5Lf/d2Lf/PT2.5 mcg/FHA5mcg/PRN 3mcg/FIM5mcg/0.5mL | |
| Tubersol Tuberculin, Purified Protein Derivative |
103941/0 | 2/24/2000 | 5 TU/mL | |
| Sanofi Pasteur SA License 1724 |
ActHIB, OmniHIB Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) |
103935/0 | 2/4/2000 | 0.5 mL/vial |
| IPOL Poliovirus Vaccine Inactivated (Monkey Kidney Cell) |
103930/0 | 2/4/2000 | 32/40/8 D AU/0.5mL | |
| Imogam, Rabies HT Rabies Immune Globulin (Human) |
103932/0 | 2/4/2000 | 150 IU/vial | |
| Imovax Rabies Rabies Vaccine |
103931/0 | 2/4/2000 | (IM) 2.5 IU/mL | |
| Typhim Vi Typhoid Vi Polysaccharide Vaccine |
103936/0 | 2/4/2000 | 25 mcg/0.5mL | |
| Talecris Biotherapeutics, Inc License 1716 |
Plasbumin Albumin (Human), USP |
101138/0 | 10/21/1942 | 5% 20% 25% |
| Prolastin Alpha-1-Proteinase Inhibitor (Human) |
103174/0 | 12/2/1987 | 500 mg/vial 1,000 mg/vial |
|
| Koate-DVI Antihemophilic Factor (Human) |
101130/0 | 1/24/1974 | 250 IU/vial 500 IU/vial 1,000 IU/vial |
|
| Thrombate III Antithrombin III (Human) |
103196/0 | 12/30/1991 | 500 IU/vial |
|
| HyperHEP S/D Hepatitis B Immune Globulin (Human) |
101146/0 | 9/23/1977 | 150 IU/mL | |
| GamaSTAN S/D Immune Globulin (Human) |
101134/0 | 1/11/1944 | 16.5% | |
| Gamunex Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified (IGIV-C) |
125046/0 | 8/27/2003 | 10% | |
| Plasmanate Plasma Protein Fraction (Human), USP |
101140/0 | 10/2/1958 | 5% | |
| HyperRAB S/D Rabies Immune Globulin (Human) |
101144/0 | 6/12/1974 | 150 IU/mL | |
| HyperRHO S/D Rho(D) Immune Globulin (Human) |
101141/0 | 6/11/1971 | 250 IU/vial 1500 IU/vial |
|
| HyperTET S/D Tetanus Immune Globulin (Human) |
101142/0 | 10/17/1957 | 250 u/syringe | |
| Wellcome Foundation Limited Wellcome Research Laboratories License 0129 |
Digibind Digoxin Immune Fab (Ovine) |
103141/0 | 4/22/1986 | 38 mg/vial |
| Wyeth Pharmaceuticals, Inc License 0003 |
ReFacto Antihemophilic Factor (Recombinant) |
103779/0 | 3/6/2000 | 250 IU/vial 500 IU/vial 1,000 IU/vial 2,000 IU/vial |
| XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin Free |
125264/0 | 2/21/2008 | 250 IU/vial 500 IU/vial 1,000 IU/vial 2,000 IU/vial |
|
| BeneFIX Coagulation Factor IX (Recombinant) |
103677/0 | 2/11/1997 | 250 IU/mL 500 IU/mL 1,000 IU/mL 2,000 IU/mL |
|
| Prevnar Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) |
103905/0 | 2/17/2000 | 0.5 mL/vial | |
| ZymoGenetics, Inc. License 1758 |
RECOTHROM Thrombin topical (Recombinant) |
125248/0 | 1/17/2008 | 5,000 IU/vial 20,000 IU/vial |
Center for Biologics Evaluation and Research
Discontinued Products List
| Applicant | Proprietary Name/ Product Name |
STN | Potency(s) | Approval Date | Date added to Discontinued list |
|---|---|---|---|---|---|
| Allermed Laboratories, Inc. | Positive Skin Test Control-Histamine | 103317/0 | 1.8 mg/mL | 2/14/1992 | 10/1/2007 |
| Baxter Healthcare Corp | Iveegam EN Immune Globulin Intravenous (Human) |
103133/0 | 500 mg/vial |
2/18/1986 | 9/24/2008 |
| Cangene Corp. | WinRho SDF |
103649/0 | 600, 1,500, 5,000 IU/vial (lyophilized powder) |
4/2/1996 | 10/1/2007 |
| Delmont Laboratories, Inc. | Staphage Lysate |
101828/0 | 8/31/1959 | 9/24/2008 | |
| Emergent BioDefense Operations Lansing Inc. | Immune Globulin (Human) | 103826/0 | 16.5 pct | 11/12/1998 | 10/1/2007 |
| Emergent BioDefense Operations Lansing Inc. | BioRab Rabies Vaccine Adsorbed, |
103820/0 | 1.0 mL/vial | 11/12/1998 | 10/1/2007 |
| Greer Laboratories, Inc. | Plague Vaccine | 103569/0 | 2 bil. cell/mL | 10/5/1994 | 10/1/2007 |
| Grifols Biologicals, Inc. | AlphaNine SD |
103249/0 | 250 IU/vial | 12/31/1990 | 9/24/2008 |
| Sanofi Pasteur, Inc. | Tetanus Toxoid | 103912/0 | 4 Lf/0.5mL | 12/9/1999 | 10/1/2007 |
| Talecris Biotherapeutics, Inc. | Gamimune-N Immune Globulin Intravenous (Human) |
101147/0 | 5% 10% |
9/11/1981 | 10/30/2008 |
| Wyeth Pharmaceuticals, Inc. | Antivenin (Crotalidae) Polyvalent | 101098/0 | 10 mL/vial | 2/8/1954 | 10/1/2007 |
| Wyeth Pharmaceuticals, Inc. | Antivenin (Micrurus fulvius) | 101099/0 | 10 mL/vial | 8/28/1967 | 10/1/2007 |
| Wyeth Pharmaceuticals, Inc. | Dryvax Smallpox Vaccine |
101106/0 | 0.25 mL/vial | 5/19/1944 | 10/1/2007 |