Drug Approvals - A
This newly approved or tentatively approved drug listing is an interim page intended to provide timely information on new drug products as a more comprehensive page is developed NDA 18-662/S-038 5/1/00 1/17/01 - - Acebutolol Hydrochloride Capsules,200 mg (base) and 400 mg (base) NDA 19-700/S-019 & 20-811/S-003 2/8/02 2/19/02 2/19/02 - AcuTect (Kit for the Preparation of ...
http://www.fda.gov/cder/orange/appendix_a.txt
3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
Prescription and OTC Drug Product List 7/2001
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE -A- AB ABLE 325MG;50MG;40MG N40390 001 JUL 23, 2001 JUL NEWA -A- AB 500MG;50MG;40MG N40394 001 JUL 23, 2001 JUL NEWA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA + WATSON LABS 325MG;7.5MG...
Prescription and OTC Drug Product List 5/2001
IRRIGANT NYSTATIN - ADD - MONARCH PHARMS EQ 40MG BASE/ML; - ADD - @ TEVA 100,000 UNITS/GM N61966 001 - ADD - 200,000 UNITS/ML N60707 001 OINTMENT; TOPICAL - DLT - NILSTAT NETILMICIN SULFATE - DLT - AT + LEDERLE 100,000 UNITS/GM N61444 001 - ADD - @ 100,000 UNITS/GM N61444 001 - DLT - INJECTABLE; INJECTION NYSTATIN - DLT - NETROMYCIN - DLT - AT ALTANA 100,000 UNITS/GM N62124 002 - DLT...
AcuTect Consumer Information
AcuTect , Kit Brand Name: AcuTect , Kit Active Ingredient: - Technetium Tc 99m Apcitide Injection Strength(s): 20mCi contains approximately 100 µg of bibapcitide radiolabeled with 20 mCi of technetium 99m Dosage Form(s): - Injection Company Name: -- Diatide, IncAcuTect is a radioactive imaging test used to...
FDA Drug Approvals List- August 1998
Drug Approvals for September 1998 Definitions and Notes September 1998 Original New Drug Applications Original Application #: 050744 Approval Date: 30-SEP-98 Trade Name: PERIOSTAT Chemical Type: 3 Therapeutic Potential: S Dosage Form: CAPSULE Applicant: COLLAGENEX INC Active Ingredient(s): DOXYCYCLINE HYCLATE OTC/RX Status: RX Indication(s): To promote attachment level gain and to...
chrmscat.p65 page 1
author: cxm9300
LIST OF APPROVED DRUGS FOR WHICH ADDITIONAL PEDIATRIC INFORMATION
Medical Imaging And Radiopharmaceutical Drug Products Technetium Tc -99m Apcitide Scintigraphic imaging of acute venous thrombosis in the lower extremities in patients who have signs and symptoms of acute venous thrombosis Medical Imaging And Radiopharmaceutical Drug Products Technetium Tc -99m Bicisate Adjunct to conventional CT or MRI...
chrmscat.p65 page 5
author: cxm9300
Diagnostic Imaging Product Portfolio
- About Berlex | Contact Us | Feedback | Site Map | Search - Patients Healthcare Professionals Clinical Trials Home - Products Diagnostic Imaging Product Portfolio A pioneer in the imaging market, Berlex has introduced a broad range of imaging agents Its contribution began in 1988 with the introduction of the worlds first Magnetic Resonance Imaging (MRI) agent, MAGNEVIST®...
Select Berlex Milestones
- About Berlex | Contact Us | Feedback | Site Map | Search - Patients Healthcare Professionals Clinical Trials Home - About Selected Berlex Milestones - 1979 Enters the U.S 1986 Enters U.S 1988 Launches MAGNEVIST® (gadopentetate dimeglumine) for Injection 1993 Launches BETAPACE® (sotalol HCI) tablets 1998 Launches LEVLITE® (levonorgestrel and ethinyl estradiol...
Feedback
Check which products you use (check all that apply) * ACUTECT ® (kit for the preparation of technetium tc 99m apcitide injection) BETASERON® (interferon beta-1b) BETAPACE® (sotalol HCI) BETAPACE AF (sotalol HCI) CAMPATH® (afemtuzumab) CLIMARA® (estradiol transdermal system) FERIDEX I.V.® (ferumoxides injectable solution) FINEVIN&...
http://www.phrma.org/newmedicines/resources/bio00.pdf
San Francisco, CA DNase recombinant Replagal Transkaryotic Therapies enzyme Fabry's disease Phase II x- galactosidase A Cambridge, MA replacement therapy G R O W T H D I S O R D E R S roduct roduct Development Name Company Category Indication Status Genotropin Pharmacia & Upjohn recombinant Prader- Willi syndrome Phase III somatropin for Peapack, NJ human growth injection hormone...
Schering: Charts Nuclear Medicine
information on Schering AG ...
author: mpt.new_media gmbh
Products Aphabetical List
- About Berlex | Contact Us | Feedback | Site Map | Search - Patients Healthcare Professionals Clinical Trials Home - Products Alphabetical Listing of Products Select a product name for more information ACUTECT ® kit for the preparation of technetium to 99m depreotide injection BETAPACE® sotalol HCI BETAPACE AF® sotalol HCI BETASERON® interferon beta...
Approved Biotechnology Drugs, 2002
Biotechnology Information, Advocacy and Business Support | About Us | BIO Events | BIO Members | Join BIO | Member Services | Links | Home CMS Payment System Prescription Coverage & Reimbursement Food & Agriculture Industrial & Environmental Bioethics & Biomedical Research Intellectual Property Regulatory Policies Tax & Fiscal Policies All Issues & Initiatives Press Releases Company...
BIO Editors &Reporters 03LIVE page 53
author: Elinor
Draxis Form 20-F for FYE 1201 as Filed SEDAR.DOC page 25
author: ChrisO
http://www.phrma.org/publications/publications//2002-10-21.601.pdf page 34
duplicates:http://www.phrma.org/newmedicines/resources/2002-10-21.93.pdf
http://www.phrma.org/newmedicines/resources/bio00.pdf page 19
20887 Acutect (Kit For The Preparation Of Tecnetium Tc99m Apcitide) Injection
Acutect (Kit For The Preparation Of Tecnetium Tc99m Apcitide) Injection Company:- Diatide, Inc Application No.:- 020-887 Approval Date:-9/14/1998 - Approval Letter, Approvable Letter, & Final Printed Labeling (837 KB) Medical Review(s) (3 MB) Chemistry Review(s) (476 KB) Pharmacology Review(s) Part 1 (1.9 MB) Part 2 (1.6 MB) Statistical Review(s) & Microbiology Review...
author: CDERUSERNAME