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Product Labeling

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This table contains a list of labels for products that have tradenames.

A list of labels for products that do not have tradenames appear in a table below this one.

Tradename Proper Name Manufacturer Labeling Format
Advate Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method Baxter Healthcare Corp (PDF)
Aralast Alpha-1-Proteinase Inhibitor (Human) Alpha Therapeutic Corp (PDF), (Text)
BabyBIG Botulism Immune Globulin Intravenous (Human) California Department of Health Services (PDF)
Biothrax Anthrax Vaccine Adsorbed BioPort Corp (PDF)
Carticel SM Service Autologous Cultured Chondrocytes Genzyme Tissue Repair (PDF), (Text)
COBAS AmpliScreen HCV Test Hepatitis C Virus Assay Roche Molecular Systems Inc (PDF Part 1), (PDF Part 2)
COBAS AmpliScreen HIV-1 Test Human Immunodeficiency Virus Type 1 Roche Molecular Systems Inc (PDF)
CroFab Crotalidae Polyvalent Immune Fab (Ovine) Protherics Inc (PDF)
Crosseal Fibrin Sealant (Human) OMRIX biopharmaceuticals, Ltd (PDF)
DAPTACEL Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) Aventis Pasteur Ltd (PDF)
DECAVAC Tetanus and Diphtheria Toxoids Adsorbed (Td), For Adult Use Aventis Pasteur Inc (PDF)
DigiFab Digoxin Immune Fab (Ovine) Protherics Inc (PDF)
Dryvax Smallpox Vaccine, Dried, Calf Lymph Type Wyeth Pharmaceuticals, Inc (PDF)
Flebogamma Immune Globulin Intravenous (Human) Instituto Grifols, SA (PDF)
FluMist Influenza Virus Vaccine, Live, Intranasal MedImmune Vaccines, Inc (PDF)
Gamunex Immune Globulin Intravenous (Human), 10% by Chromatography Process Bayer Corp (PDF)
Genetic Systems HIV-1 / HIV-2 Peptide EIA Human Immunodeficiency Virus Types 1 & 2 (Synthetic Peptide) Genetic Systems Corp (PDF)
Infanrix Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed GlaxoSmithKline Biologicals (PDF)
OCTAGAM Immune Globulin Intravenous (Human) OCTAPHARMA Pharmazeutika Produktionsges.m.b.H. (PDF)
OraQuick Rapid HIV-1 Antibody Test   OraSure Technologies (PDF)
Kogenate FS, Helixate FS Antihemophilic Factor (Recombinant) Bayer Corp (PDF)
PACIS BCG, Live BioChem Pharma Inc (PDF)
Pediarix Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined SmithKline Beecham Biologicals (PDF)
Prevnar Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Lederle Laboratories
Division American Cyanamid Company
(PDF)
Procleix HIV-1 / HCV Assay Gen-Probe, Inc (PDF)
ReFacto Antihemophilic Factor (Recombinant) Genetics Institute, Inc (PDF)
Rhophylac Rho(D) Immune Globulin Intravenous (Human) ZLB Bioplasma AG (PDF)
Tripedia Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine, Adsorbed Aventis Pasteur, Inc (PDF)
TWINRIX Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine SmithKline Beecham Biologicals (PDF)
Zemaira Alpha-1-Proteinase Inhibitor (Human) Aventis Behring LLC (PDF)

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List of labels for products that do not have a tradename

Proper Name Manufacturer Labeling Format
Blood Grouping Reagent Combination Kit Micro Typing Systems, Inc (PDF)
Tetanus and Diphtheria Toxoids Adsorbed For Adult Use Aventis Pasteur Ltd (PDF)

 

Transfer of Therapeutic Products to CDER

 

 
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