Therapeutic Biological Approvals 125057 / 0 Abbott Laboratories 200 Abbott Park Road D-491, AP30–1E Abbott Park, IL 60064-6157 License 0043 12/31/2002 Indiclor Indium -In-111 Chloride Sterile Solution Addition of a "Geriatric Use" subsection in the package insert 19862 / 12 Medi-Physics, Inc, dba Amersham Health 101 Carnegie Center Princeton, NJ 08540 4/24/2003 Indiclor Indium ...
DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT Food and Drug Administration • Center for Drug Evaluation and Research Approved Drug Products Search DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST ANTICOAGULANT CITRATE DEXTROSE SOLUTION (ACD) INJECTABLE; INJECTION ACD-A SOLUTION GAMBRO BCT, INC ANDA N010228 FEB 25, 2002 - ANTICOAGULANT CITRATE...
author: USERNAME
NDA Supplement Approval- Indium IN-111 Chloride Sterile Solution, Medi-Physics FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Product Approval Information - New Drug Application Product name: Indium In-111 Chloride Solution (Indiclor) Manufacturer: Medi-Physics, Inc d.b.a
NDA Supplement Approval - Indium-In-111 Chloride Sterile Solution, Indiclor, Medi-Physics, Inc FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Product Approval Information - New Drug Application Product name: Indium -In-111 Chloride Sterile Solution Tradename: Indiclor Manufacturer: Medi-Physics, Inc, dba Amersham Health, Princeton, NJ 08540 Revised Package Insert: Addition of a "Geriatric Use" subsection in...
Label - Indiclor, High Purity Indium chloride In-111 Sterile Solution lPAF INDICLORm High Purity lndium Chloride In- 111 Sterile Solution Diagnostic- For use in Radiolabeling OncoScint, ProstaScint, and Zevalin For single dose, single use only DESCRIPTION INDICLOR lndium In- ill Chloride is a diagnostic radiopharmaceutical intended for radiolabeling OncoScint (satumomab pendetide) or ProstaScint (capromab pendetide) used for in...
author: CBER
Label - Indiclor, High Purity Indium chloride In-111 Sterile Solution page 8
author: CBER
duplicates:http://www.fda.gov/cber/label/in111med021902LB.pdf
Label - Indiclor, High Purity Indium chloride In-111 Sterile Solution page 7
author: CBER
duplicates:http://www.fda.gov/cber/label/in111med021902LB.pdf
Label - Indiclor, High Purity Indium chloride In-111 Sterile Solution page 6
author: CBER
duplicates:http://www.fda.gov/cber/label/in111med021902LB.pdf
Label - Indiclor, High Purity Indium chloride In-111 Sterile Solution page 2
author: CBER
duplicates:http://www.fda.gov/cber/label/in111med021902LB.pdf
Label - Indiclor, High Purity Indium chloride In-111 Sterile Solution page 1
author: CBER
duplicates:http://www.fda.gov/cber/label/in111med021902LB.pdf
Indiclor (Indium In-111 Chloride-Sterile Solution) - Product Approval Information - New Drug Application Risley: We acknowledge receipt of your supplemental drug application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for the following: Indiclor (Indium In-111 Chloride -Sterile Solution) NDA Number: 19-862 Supplement Number: 6 Date of Supplement: November 13, 2001 Date of Receipt: November 26, 2001 This prior approval supplemental...
Indium-IN 111 Chloride Sterile Solution (Indicor) - Package Insert 1 PAF INDIClORM High Purity Indium Chloride In- 111 Sterile Solution Diagnostic- For use in Radiolabeling OncoScint, ProstaScint, and Zevalin For single dose, single use only DESCRIPTION INDICLOR Indium In- 111 Chloride is a diagnostic radiopharmaceutical intended for radiolabeling OncoScint (satumomab pendetide) or ProstaScint (capromab...
author: CBER FDA
subject: dob071803
Indium-IN 111 Chloride Sterile Solution (Indicor) - Package Insert page 9
author: CBER FDA
subject: dob071803
Indium-IN 111 Chloride Sterile Solution (Indicor) - Package Insert page 7
author: CBER FDA
subject: dob071803
Indium-IN 111 Chloride Sterile Solution (Indicor) - Package Insert page 6
author: CBER FDA
subject: dob071803
Indium-IN 111 Chloride Sterile Solution (Indicor) - Package Insert page 3
author: CBER FDA
subject: dob071803
CBER Transfer of Therapeutic Products to CDER Alteplase Activase Genentech, Inc Anakinra Kineret Amgen, Inc Anistreplase Eminase Wulfing Pharma GmbH Arcitumomab CEA-Scan Immunomedics, Inc Asparaginase Elspar Merck & Co., Inc Basiliximab Simulect Novartis Pharmaceuticals Corp Becaplermin Regranex OMJ Pharmaceuticals, Inc Becaplermin Concentrate - Chiron Corp Botulinum Toxin Type A BOTOX BOTOX COSMETIC Allergan, Inc Botulinum...
author: FDA / CBER
ecsec505 DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST ANTICOAGULANT CITRATE DEXTROSE SOLUTION (ACD) INJECTABLE; INJECTION ACD-A SOLUTION GAMBRO BCT, INC ANDA N010228 FEB 25, 2002 - ANTICOAGULANT CITRATE DEXTROSE SOLUTION (ACD) INJECTABLE; INJECTION ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A HAEMONETICS...
http://www.fda.gov/cder/da/ddpa93.wpd 19-862 INDICLOR AMERSHAM INDIUM IN111 CHLORIDE 12-29-92 (INJECTABLE) ARLINGTON HEIGHTS, IL N/A 60005 (DIAGNOSTIC) THE FOLLOWING DATA IS RECEIVED FROM THE CENTER FOR DEVICES AND RADIOLOGICAL HEALTH AND IS NOT EDITED BY THE DIVISION OF DRUG INFORMATION RESOURCES PRIOR TO PUBLICATION P890045 GELSEAL CARBOMEDICS APPROVAL FOR THE 01/11/93 AUSTIN, TX GELSEAL VASCULAR...
Label - Indiclor, High Purity Indium chloride In-111 Sterile Solution page 10
author: CBER
duplicates:http://www.fda.gov/cber/label/in111med021902LB.pdf
Label - Indiclor, High Purity Indium chloride In-111 Sterile Solution page 9
author: CBER
duplicates:http://www.fda.gov/cber/label/in111med021902LB.pdf
Label - Indiclor, High Purity Indium chloride In-111 Sterile Solution page 5
author: CBER
duplicates:http://www.fda.gov/cber/label/in111med021902LB.pdf
Label - Indiclor, High Purity Indium chloride In-111 Sterile Solution page 4
author: CBER
duplicates:http://www.fda.gov/cber/label/in111med021902LB.pdf
Label - Indiclor, High Purity Indium chloride In-111 Sterile Solution page 3
author: CBER
duplicates:http://www.fda.gov/cber/label/in111med021902LB.pdf
Cytogen: ProstaScint Information Each ProstaScint kit consists of two vials which contain all of the non-radioactive ingredients necessary to produce a single unit dose of indium In 111 ProstaScint, an immunoscintigraphic agent for administration by intravenous injection only.indium In 111 Chloride ...
