ACAM2000
Smallpox and Mpox (Vaccinia) Vaccine, Live |
8/29/2024 |
Package Insert
Clinical Review
Statistical Review |
ADACEL
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed |
1/9/2023 |
Package Insert
Clinical Review
Statistical Review |
Advate
Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method |
12/14/2011 |
Package Insert
Clinical Review
Statistical Review and Evaluation |
ADYNOVATE
Antihemophilic Factor (Recombinant), PEGylated |
12/22/2016 |
Package Insert
Statistical Review
Clinical Review |
11/13/2015 |
Package Insert
Statistical Review
Clinical Review |
Afluria
Influenza Virus Vaccine |
10/4/2018 |
Package Insert |
11/10/2009 |
Package Insert
Statistical Review and Evaluation
Clinical Review |
AFLURIA QUADRIVALENT
Influenza Vaccine |
10/4/2018 |
Package Insert
Clinical Review
Statistical Review
Statistical Review Addendum |
8/31/2017 |
Package Insert
Clinical Review
Statistical Review |
AFSTYLA
Antihemophilic Factor (Recombinant), Single Chain |
5/25/2016 |
Package Insert
Statistical Review
Clinical Review |
Agriflu
Influenza Virus Vaccine |
1/28/2020 |
Package Insert
Clinical Review
Statistical Review |
Artiss
Fibrin Sealant (Human) |
3/19/2008 |
Package Insert
Statistical Review and Evaluation
Clinical Review |
ASCENIV
Immune Globulin Intravenous, Human-slra, 10% Liquid |
4/1/2019 |
Package Insert
Statistical Review
Clinical Review |
AUDENZ
Influenza A (H5N1) Monovalent Vaccine, Adjuvanted |
1/31/2020 |
Package Insert
Clinical Review
Statistical Review |
BEXSERO
Meningococcal Group B Vaccine |
1/23/2015 |
Package Insert
Statistical Review
Clinical Review |
BIVIGAM
Immune Globulin Intravenous (Human), 10% |
12/8/2023 |
Package Insert
Clinical Review
Statistical Review |
BOOSTRIX
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed |
10/7/2022 |
Package Insert
Clinical Review
Statistical Review |
Cervarix
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant |
7/14/2011 |
Statistical Review and Evaluation
Clinical Review |
10/16/2009 |
Package Insert
Statistical Review and Evaluation
Clinical Review Memo |
COMIRNATY
COVID-19 Vaccine, mRNA |
9/11/2023 |
Package Insert
Clinical Review
Statistical Review |
7/8/2022 |
Package Insert
Clinical Review
Statistical Review |
8/23/2021 |
Package Insert
Clinical Review
Statistical Review
Statistical Review
Statistical Review |
CUTAQUIG
Immune Globulin Subcutaneous (Human) -hipp, 16.5% |
10/22/2021 |
Package Insert
Clinical Review
Statistical Review |
CUVITRU
Immune Globulin Subcutaneous (Human), 20% Solution |
9/13/2016 |
Package Insert
Clinical Review
Statistical Review |
Daptacel
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed |
3/12/2008 |
Package Insert
Clinical Review |
DENGVAXIA
DENGUE Tetravalent Vaccine, Live |
6/30/2023 |
Package Insert
Clinical Review
Statistical Review |
5/1/2019 |
Package Insert
Clinical Review
Statistical Review |
ERVEBO
Ebola Zaire Vaccine, Live |
7/27/2023 |
Package Insert
Clinical Review
Statistical Review |
ESPEROCT
Antihemophilic Factor (Recombinant), GlycoPEGylated-exei |
2/19/2019 |
Package Insert
Clinical Review
Statistical Review |
Evicel
Fibrin Sealant (Human) |
1/2/2008 |
Package Insert
Clinical Efficacy Supplement Final Review Memo
Statistical Review and Evaluation |
FIBRYGA
Fibrinogen (Human) |
7/31/2024 |
Package Insert
Clinical Review
Statistical Review |
12/23/2020 |
Package Insert
Clinical Review
Statistical Review
Clinical Pharmacology Supplemental Review |
6/7/2017 |
Package Insert
Clinical Review
Statistical Review |
FLUAD
Influenza Vaccine, Adjuvanted |
10/28/2020 |
Package Insert
Clinical Review
Statistical Review |
FLUAD QUADRIVALENT
Influenza Vaccine, Adjuvanted |
12/4/2020 |
Package Insert |
10/28/2020 |
Clinical Review
Statistical Review |
Fluarix
Influenza Virus Vaccine |
10/19/2009 |
Package Insert
Statistical Review and Evaluation
Clinical Review |
Fluarix Quadrivalent
Influenza Virus Vaccine |
1/11/2018 |
Package Insert
Clinical Review
Statistical Review |
12/14/2012 |
Package Insert
Clinical Review
Statistical Review and Evaluation |
Flucelvax
Influenza Vaccine |
5/23/2016 |
Package Insert
Statistical Review
Clinical Review Addendum |
Flucelvax Quadrivalent
Influenza Vaccine |
10/14/2021 |
Package Insert
Clinical Review
Statistical Review |
3/3/2021 |
Package Insert
Clinical Review
Statistical Review |
5/23/2016 |
Package Insert
Clinical Review
Statistical Review Addendum
Statistical Review |
FluLaval
Influenza Virus Vaccine |
11/18/2016 |
Package Insert
Clinical Review
Statistical Review and Evaluation
Statistical Review Assay |
8/16/2013 |
Package Insert
Clinical Review
Statistical Review and Evaluation |
FluLaval Quadrivalent
Influenza Virus Vaccine |
11/18/2016 |
Package Insert
Clinical Review
Statistical Review and Evaluation
Statistical Review Assay |
8/15/2013 |
Package Insert
Statistical Review and Evaluation
Final Clinical Review |
FluMist Quadrivalent
Influenza Vaccine Live, Intranasal |
2/29/2012 |
Package Insert
Clinical Review
Statistical Review and Evaluation |
Fluzone High-Dose Quadrivalent
Influenza Virus Vaccine |
1/23/2019 |
Package Insert
Clinical Review
Statistical Review |
6/7/2013 |
Package Insert
Clinical Review
Statistical Review and Evaluation |
Gammagard Liquid
Immune Globulin Infusion (Human) |
7/22/2011 |
Package Insert
Clinical Review
Statistical Review and Evaluation |
Gammaplex
Immune Globulin Intravenous (Human) 5% Liquid |
7/30/2015 |
Package Insert
Clinical Review
Statistical Review |
Gamunex-C
Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified
|
12/4/2015 |
Package Insert
Clinical Review
Clinical Pharmacology Review |
Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant |
12/22/2010 |
Package Insert
Clinical Review
Statistical Review and Evaluation |
10/16/2009 |
Package Insert
Clinical Review
Statistical Review |
9/12/2008 |
Package Insert
Clinical Review
Statistical Review and Evaluation |
Gardasil 9
Human Papillomavirus 9-valent Vaccine, Recombinant |
6/12/2020 |
Package Insert
Clinical Review |
10/7/2016 |
Package Insert
Clinical Review
Statistical Review |
12/10/2014 |
Package Insert
Clinical Review
Statistical Review |
Grastek
Timothy Grass Pollen Allergen Extract |
4/11/2014 |
Package Insert
Clinical Review
Statistical Review |
Hemacord
Hematopoietic progenitor cells, cord blood |
11/10/2011 |
Package Insert
Clinical and Statistical Joint Review |
Hiberix
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) |
1/14/2016 |
Package Insert
Clinical Review
Statistical Review |
8/19/2009 |
Package Insert
Clinical Review
Statistical Review |
Hizentra
Immune Globulin Subcutaneous (Human), 20% Liquid |
9/25/2013 |
Package Insert |
10/3/2011 |
Package Insert
Statistical Review and Evaluation
Clinical Review |
2/17/2011 |
Package Insert
Clinical Review |
HYQVIA
Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase |
4/7/2023 |
Package Insert
Clinical Review
Statistical Review |
Ixiaro
Japanese Encephalitis Vaccine, Inactivated, Adsorbed |
4/13/2018 |
Package Insert
Clinical Review
Statistical Review |
5/17/2013 |
Package Insert
Clinical Review
Statistical Review and Evaluation |
IXINITY
Coagulation Factor IX (Recombinant) |
3/22/2024 |
Package Insert
Statistical Review
Clinical Review
Clinical Pharmacology Review |
11/17/2022 |
Package Insert
Clinical Review
Statistical Review |
4/29/2015 |
Package Insert
Clinical Review 1
Clinical Review 2
Clinical Review 3
Statistical Review and Evaluation |
JIVI
Antihemophilic Factor (Recombinant), PEGylated-aucl |
8/29/2018 |
Package Insert
Clinical Review
Statistical Review |
Kedbumin
Albumin (Human) 25% |
6/3/2011 |
Package Insert
Clinical Review
Statistical Review and Evaluation |
KEDRAB
Rabies Immune Globulin (Human) |
5/17/2021 |
Package Insert
Clinical Review
Preclinical Pharm-Tox Review
Statistical Review |
Kogenate FS
Antihemophilic Factor (Recombinant) |
10/10/2008 |
Package Insert
Clinical Review |
KINRIX
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine |
6/24/2008 |
Package Insert
Clinical Review
Statistical Review |
KOVALTRY
Antihemophilic Factor (Recombinant) |
3/16/2016 |
Package Insert (Vial Adapter)
Package Insert (BIO-SET)
Clinical Review
Statistical Review |
Menactra
Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine |
4/22/2011 |
Package Insert
Clinical Review
Statistical Review
Pharmacovigilance Plan Review |
MenHibrix
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine |
6/14/2012 |
Package Insert
Statistical Review and Evaluation
Clinical Review |
MenQuadfi
Meningococcal (Groups A, C, Y, W) Conjugate Vaccine |
4/23/2020 |
Package Insert
Clinical Review
Statistical Review |
Menveo
Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine |
8/1/2013 |
Package Insert
Clinical Review
Statistical Review |
1/28/2011 |
Package Insert
Clinical Review
Statistical Review |
2/19/2010 |
Package Insert
Clinical Review
Statistical Review |
M-M-R II
Measles, Mumps and Rubella Virus Vaccine Live |
2/27/2023 |
Package Insert
Clinical Review
Statistical Review |
Novoeight
Antihemophilic Factor (Recombinant) |
10/15/2013 |
Package Insert
Clinical Review
Statistical Review and Evaluation |
NUWIQ
Antihemophilic Factor (Recombinant) |
9/4/2015 |
Package Insert
Clinical Review
Statistical Review |
Octaplas
Pooled Plasma (Human), Solvent/Detergent Treated |
2/25/2021 |
Package Insert
Clinical Memo |
3/29/2019 |
Package Insert
Clinical Review |
ODACTRA
House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract |
1/20/2023 |
Package Insert
Clinical Review
Statistical Review |
ORALAIR
Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract |
11/9/2018 |
Package Insert & Medication Guide
Statistical Review
Clinical Review |
4/1/2014 |
Package Insert
Statistical Review
Clinical Review |
PALFORZIA
Peanut (Arachis hypogaea) Allergen Powder-dnfp |
7/26/2024 |
Package Insert
Clinical Review
Statistical Review |
1/31/2020 |
Package Insert
Clinical Review
Statistical Review |
PANZYGA
Immune Globulin Intravenous, human-ifas |
8/2/2018 |
Package Insert
Clinical Review
Statistical Review |
PENBRAYA
Meningococcal Groups A, B, C, W, and Y Vaccine |
10/20/2023 |
Package Insert
Clinical Review
Statistical Review |
Pentacel
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine |
6/20/2008 |
Package Insert
Clinical Review
Statistical Review
Recommendations regarding request for partial waiver of pediatric studies |
Prevnar 13
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) |
1/25/2013 |
Package Insert
Clinical Review
Statistical Review and Evaluation |
2/24/2010 |
Package Insert
Clinical Review
Statistical Review and Evaluation |
PREVNAR 20
Pneumococcal 20-valent Conjugate Vaccine |
4/27/2023 |
Package Insert
Clinical Review
Statistical Review |
PRIORIX
Measles, Mumps and Rubella Vaccine, Live |
6/3/2022 |
Package Insert
Clinical Review
Statistical Review |
PROQUAD
Measles, Mumps, Rubella and Varicella Virus Vaccine Live |
2/27/2023 |
Package Insert (Frozen)
Package Insert (Refrigerated)
Clinical Review
Statistical Review |
Q-Pan
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted |
9/9/2016 |
Package Insert
Clinical Review
Statistical-Clinical Review
Statistical-Clinical Review - Addendum |
Quadracel
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine |
3/24/2015 |
Package Insert
Clinical Serology and Bioassay Review, and Approval Memo
Clinical Statistical Review |
RAGWITEK
Short Ragweed Pollen Allergen Extract (Ambrosia artemisiifolia) |
4/16/2021 |
Package Insert
Clinical Review
Statistical Review |
REBINYN
Coagulation Factor IX (Recombinant), GlycoPEGylated |
5/31/2017 |
Package Insert
Clinical Review
Statistical Review |
RECOTHROM
Thrombin, topical (Recombinant) |
3/15/2013 |
Package Insert
Clinical Review
Final Clinical Labeling Memo |
Rixubis
Coagulation Factor IX (Recombinant) |
9/12/2014 |
Package Insert
Clinical Review
Statistical Review |
Rotarix
Rotavirus Vaccine, Live, Oral |
4/3/2008 |
Package Insert
Clinical Review
Statistical Review and Evaluation |
RotaTeq
Rotavirus Vaccine, Live, Oral, Pentavalent |
2/23/2017 |
Package Insert
Clinical Review
Statistical Review |
Rubber Panel T.R.U.E. TEST
Rubber Panel Thin-Layer Rapid Use Epicutaneous Patch Test |
3/3/2017 |
Package Insert
Clinical Review
Statistical Review |
SEVENFACT
coagulation factor VIIa (recombinant)-jncw |
11/22/2022 |
Package Insert
Clinical Review |
4/1/2020 |
Package Insert
Clinical Review
Statistical Review |
SPIKEVAX
COVID-19 Vaccine, mRNA |
9/11/2023 |
Package Insert
Clinical Review
Statistical Review |
TachoSil
TACHOSIL® Fibrin Sealant Patch |
7/15/2015 |
Package Insert
Clinical Review
Statistical Review |
TICOVAC
Tick-Borne Encephalitis Vaccine |
8/13/2021 |
Package Insert
Clinical Review
Statistical Review |
TISSEEL
Fibrin Sealant |
1/25/2012 |
Package Insert
Clinical Review
Statistical Review and Evaluation |
T.R.U.E. TEST
Thin-Layer Rapid Use Epicutaneous Patch Test |
8/25/2017 |
Package Insert
Clinical Review
Statistical Review |
TRUMENBA
Meningococcal Group B Vaccine |
4/14/2016 |
Package Insert
Clinical Review
Statistical Review
Addendum to Statistical Review |
10/29/2014 |
Package Insert
Clinical Review
Statistical Review |
VARIVAX
Varicella Virus Vaccine Live |
2/27/2023 |
Package Insert (Frozen)
Package Insert (Refrigerated)
Clinical Review
Statistical Review |
VAXCHORA
Cholera Vaccine, Live, Oral |
12/23/2020 |
Package Insert
Clinical Review
Statistical Review |
VAXELIS
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine |
12/21/2018 |
Package Insert
Clinical Review
Statistical Review |
VAXNEUVANCE
Pneumococcal 15-valent Conjugate Vaccine |
6/17/2022 |
Package Insert
Clinical Review
Statistical Review |
VISTASEAL
FIBRIN SEALANT (Human) |
9/27/2024 |
Package Insert |
Voluven
6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection |
5/17/2012 |
Package Insert
Clinical Review (BN070012/145)
Statistical Review and Evaluation (BN070012/145) |
12/27/2008 |
Package Insert
Clinical PREA Review Memo
Clinical Pharmacology |
Wilate
von Willebrand Factor/Coagulation Factor VIII Complex (Human) |
3/22/2024 |
Package Insert
Clinical Review |
12/1/2023 |
Package Insert
Clinical Pharmacology Review
Clinical Review
Statistical Review |
9/25/2019 |
Package Insert
Clinical Review
Statistical Review |
8/5/2015 |
Package Insert
Clinical Review
Statstical Review |
XEMBIFY
Immune Globulin Subcutaneous, Human - klhw, 20% |
7/18/2024 |
Package Insert
Clinical and Clinical Pharmacology Review
Statistical Review |
7/3/2019 |
Package Insert
Clinical Review
Statistical Review |
XYNTHA
Antihemophilic Factor (Recombinant), Plasma/Albumin Free |
8/13/2020 |
Package Insert
Package Insert
Clinical Review
Statistical Review |
YIMMUGO
immune globulin intravenous, human-dira |
6/13/2024 |
Package Insert
Clinical Review
Statistical Review |