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1996 and Older - New Drug Application (NDA)
018654/S018 S029 S030 11/31/1996 3/18/1997 11/20/1997 Wellbutrin Glaxo Wellcome 018644/S10,12, 13 10/31/96 6/17/2003 Xanax Tablets/Alprazolam [2 MB] Pharmacia and Upjohn 018276/S033 11/26/1996 11/20/1997 Zantac Syrup/Ranitidine HCl [1 MB] Glaxo-Wellcome 019675 12/30/1988 2/4/1998 Zebeta (Bisoprolol Fumarate) Tablets , 5 & 10 mg Lederle Laboratories 19-982 6/11/93 8/1/2001 Zebeta ...
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http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA,...
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FDA Drug Approvals List- May 1998
In this setting, INTEGRILIN has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction, or need for urgent intervention Original Application #: 020774 Approval Date: 15-MAY-98 Trade Name: PERIO CHIP Chemical Type: 3 Therapeutic Potential: S Dosage Form: CHIP Applicant: PERIO PRODUCTS LTD Active Ingredient(s): CHLORHEXIDINE GLUCONATE OTC/RX Status:...
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DDPA June 1995
74-423 CAPTOPRIL MOVA CAPTOPRIL 07-JUN-95 (TABLET) CAGUAS, PR 12.5MG 00725 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 17-911 CLINORIL MERCK SULINDAC 01-JUN-95 (TABLET) WEST POINT, PA 150MG 19486 200MG (LABELING REVISION -- PRECAUTIONS; ADVERSE REACTIONS) 16-744* NORIDAY 1+50-FE SYNTEX FERROUS FUMARATE 02-JUN-95 (TABLET) PALO...
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Drug and Device Approvals March 1995
74-322 CAPTOPRIL NOVOPHARM CAPTOPRIL 20-MAR-95 (TABLET) WILSON, NC 12.5MG 27396 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) 74-434 CAPTOPRIL MYLAN CAPTOPRIL 22-MAR-95 (TABLET) MORGANTOWN, WV 12.5MG 26505 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) 74-451 CAPTOPRIL ROYCE LABS CAPTOPRIL 31-MAR-95 (TABLET) MIAMI, FL 12.5MG 33014 25MG 50MG 100MG (ANGIOTENSIN...
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DDPA January 1996
74-467 RANITIDINE GENEVA PHARM RANITIDINE 31-JAN-96 (TABLET) BRO OMFIELD, CO 150MG 80038 300MG (HISTAMINE H-2 RECEPTOR ANTAGONIST) 74-475 TERFENADINE BAKER NORTON TERFENADINE 31-JAN-96 (TABLET) MIAMI, FL 60MG 33178 (ANTIHISTAMINE) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 20-280 GENOTROPIN PHARMACIA SOMATROPIN, BIOSYNTHETIC 20-DEC-95 (INJECTABLE) COLUMBUS, OH 5.8MG/VIAL 43216 ...
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http://www.fda.gov/cder/da/ddpa93.wpd
19 050 SUFENTA JANSSEN SUFENTANIL CITRATE 03 19 93 (INJECTABLE) PISCATAWAY, NJ EQ 0.05MG BASE/ML 08854 (REVISED LABELING DESCRIPTION; CLINICAL PHARMACOLOGY; CLINICAL STUDIES; INDICATIONS AND USAGE; WARNINGS; PRECAUTIONS; ADVERSE REACTIONS; OVERDOSAGE; DOSAGE AND ADMINISTRATION) 19 898 PRAVACHOL BRISTOL MYERS SQUIBB PRAVASTATIN SODIUM 03 22 93 (TABLET) PRINCETON, NJ 10MG 08543 20MG...
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http://www.fda.gov/cder/da/ddpa91.wpd
19 531 NUTRILI 10% MCGAW SOYBEAN OIL 02 08 91 (INJECTABLE) IRVINE, CA 10% 92713 (NUTRIENT REPLENISHER) 19 531 NUTRILI 20% MCGAW SOYBEAN OIL 02 08 91 (INJECTABLE) IRVINE, CA 20% 92713 (NUTRIENT REPLENISHER) 20-069 DIANEAL PD-2 BAXTER CALCIUM CHLORIDE 02-19-91 ELECTROLYTE ROUND LAKE, IL 514MG/100ML CONCENTRATE 60073 MAGNESIUM CHLORIDE IN PLASTIC CONTAINER 102MG/100ML (SOLUTION) SODIUM...
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Angiotensin-converting enzyme (ACE) inhibitors - [Medication] - Quest Diagnostics Patient Health Library
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Angiotensin-converting enzyme (ACE) inhibitors - [Medication] - Quest Diagnostics Patient Health Library Angiotensin-converting enzyme (ACE) inhibitors - [Medication] - Quest Diagnostics Patient Health Library Accupril, ACE, ACE Inhibitors, Aceon, Altace,...
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Angiotensin-converting enzyme (ACE) inhibitors for coronary artery disease - [Medication] - Quest Diagnostics Patient Health
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Angiotensin-converting enzyme (ACE) inhibitors for coronary artery disease - [Medication] - Quest Diagnostics Patient Health Angiotensin-converting enzyme (ACE) inhibitors for coronary artery disease - [Medication] - Quest Diagnostics Patient Health Accupril...
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Immunotherapy for allergies to insect stings - Quest Diagnostics Patient Health Library
Immunotherapy for allergies to insect stings Treatment Overview Immunotherapy is a series of allergy shots given to reduce your sensitivity to allergens that cause an allergic reaction. The treatment also is sometimes called venom immunotherapy (VIT). Paper wasps. 1 A variation of the treatment called rush immunotherapy may be considered to quickly increase your tolerance to...
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Coughs - Quest Diagnostics Patient Health Library
Coughs Topic Overview Coughing is the body's way of removing foreign material or mucus from the lungs and upper airway passages or of reacting to an irritated airway. The mucus may have drained down the back of the throat from the nose or sinuses ( postnasal drainage ) or may have come up from the lungs. It is normal to have a productive cough when you have a common cold.
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Angiotensin-converting enzyme (ACE) inhibitors for heart attack and unstable angina - [Medication] - Quest Diagnostics Patient
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Angiotensin-converting enzyme (ACE) inhibitors for heart attack and unstable angina - [Medication] - Quest Diagnostics Patient Angiotensin-converting enzyme (ACE) inhibitors for heart attack and unstable angina - [Medication] - Quest Diagnostics Patient...
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Angiotensin-converting enzyme (ACE) inhibitors - [Medication] - Quest Diagnostics Patient Health Library
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Angiotensin-converting enzyme (ACE) inhibitors - [Medication] - Quest Diagnostics Patient Health Library Angiotensin-converting enzyme (ACE) inhibitors - [Medication] - Quest Diagnostics Patient Health Library Accupril, ACE, ACE Inhibitors, Aceon, Altace,...
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Angiotensin-converting enzyme (ACE) inhibitors for coronary artery disease - [Medication] - Quest Diagnostics Patient Health
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Angiotensin-converting enzyme (ACE) inhibitors for coronary artery disease - [Medication] - Quest Diagnostics Patient Health Angiotensin-converting enzyme (ACE) inhibitors for coronary artery disease - [Medication] - Quest Diagnostics Patient Health Accupril...
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AstraZeneca International - pharmaceutical company, prescription drugs, medicine manufacturers
Skip to content Home Media Investors Careers Products Licensing Research Responsibility About us Contact us - - Zestoretic (lisinopril dihydrate - hydrochlorothiazide) Zestoretic (lisinopril dihydrate - hydrochlorothiazide) is a fixed-dose combination of the ACE inhibitor, lisinopril dihydrate, and the diuretic, hydrochlorothiazide, for hypertension. Zestoretic is in-licensed from...
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AstraZeneca Products - Drug information, prescription medicines, pharmaceuticals
Skip to content Home Media Investors Careers Products Cardiovascular Gastrointestinal Infection Neuroscience Oncology Respiratory Non pharma businesses Licensing Research Responsibility About us Contact us Home - -Products - - Products Our skills and resources are concentrated on six important areas of healthcare - representing the majority of the worldwide burden of disease. We...
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Zestoretic (lisinopril dihydrate-hydrochlorothiazide) - combination treatment for hypertension
Skip to content Home Media Investors Careers Products Cardiovascular Gastrointestinal Infection Neuroscience Oncology Respiratory Non pharma businesses Licensing Research Responsibility About us Contact us Home - - Products - -Cardiovascular - - Zestoretic (lisinopril dihydrate - hydrochlorothiazide) Zestoretic (lisinopril dihydrate - hydrochlorothiazide) is a fixed-dose combination...
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AstraZeneca Products - Drug information, prescription medicines, pharmaceuticals
Skip to content Home Media Investors Careers Products Cardiovascular Gastrointestinal Infection Neuroscience Oncology Respiratory Non pharma businesses Licensing Research Responsibility About us Contact us Home - -Products - - Products Our skills and resources are concentrated on six important areas of healthcare - representing the majority of the worldwide burden of disease. We...
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AstraZeneca Products - Drug information, prescription medicines, pharmaceuticals
Skip to content Home Media Investors Careers Products Cardiovascular Gastrointestinal Infection Neuroscience Oncology Respiratory Non pharma businesses Licensing Research Responsibility About us Contact us Home - -Products - - Products Our skills and resources are concentrated on six important areas of healthcare - representing the majority of the worldwide burden of disease. We...
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AstraZeneca Products - Cardiovascular - Hypertension, beta blockers, high cholesterol
Skip to content Home Media Investors Careers Products Cardiovascular Gastrointestinal Infection Neuroscience Oncology Respiratory Non pharma businesses Licensing Research Responsibility About us Contact us Home - - Products - -Cardiovascular - - Cardiovascular Cardiovascular disease accounts for 17 million deaths worldwide each year, making it the greatest risk to life for most...
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AstraZeneca Products - Drug information, prescription medicines, pharmaceuticals
Skip to content Home Media Investors Careers Products Cardiovascular Gastrointestinal Infection Neuroscience Oncology Respiratory Non pharma businesses Licensing Research Responsibility About us Contact us Home - -Products - - Products Our skills and resources are concentrated on six important areas of healthcare - representing the majority of the worldwide burden of disease. We...
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Drug Approvals - Z
Bristol-Myers Squibb Company NDA 20-412/S17, S18 & 20-413/S8, S9 2/20/02 2/21/02 ZERIT (stavudine) for Oral Solution Bristol-Myers Squibb Company NDA 20-413/S6 10/16/01 4/25/03 Zestoretic (lisinopril/hydrochlorothiazide) Tablets, 20/12.5, 20/25 and 10/12.5 mg, Rx AstraZeneca Pharmaceuticals LP NDA 19-888/S-035 4/17/03 Zestril (lisinopril) Tablet, 2.5, 5, 10, 20, 30 & 40...
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2002 AstraZeneca Annual Report and Form 20-F
2002 AstraZeneca Annual Report and Form 20-F www.astrazeneca.com In Brief Key Achievements Financial Highlights Key Product Summary Development Pipeline Contact Information Chairman/CE/Board Chairman's Statement Chief Executive's Review Board of Directors Operational Review Strategy Key Product Summary Review by Therapeutic Area Research & Development (R&D;) Commercialisation and...
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AstraZeneca Annual Report and Form 20-F 1999
Major Pharmaceutical Products - - - TRADE MARKS COMPOUND MAIN USES Gastrointestinal - - Losec/Prilosec omeprazole Proton pump inhibitor for peptic ulcer, reflux oesophagitis, heartburn and dyspepsia Losec MUPS omeprazole Omeprazole in a Multiple Unit Pellet System tablet formulation Entocort budesonide Anti-inflammatory for inflammatory bowel diseases, such as ulcerative colitis and...
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