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Drug Approvals - Z
Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted ZADITOR (ketotifen fumarate ophthalmic solution) 0.025%, Rx Ciba Vision NDA 21-066 7/2/99 7/6/99 7/6/99 3/31/02 ZADITOR (ketotifen fumarate ophthalmic solution) 0.025%, Rx Ciba Vision NDA 21-066/S4 07/20/01 05/08/03 - ZADITOR Indication: for the prevention of itching of the eye due to allergic...
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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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http://www.fda.gov/cder/reports/cderfact.pdf page 23
author: Carolyn Spencer
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http://www.fda.gov/cder/reports/cderfact.pdf
pylori detection kit Manufacturer SmithKline Beecham Organon Lilly Pharmacia and Upjohn Boehringer Ingelheim Zeneca Gilead Glaxo Wellcome Hoechst Marion Roussel Parke Davis Enviroderm Advanced Magnetics Allergan Meretek Generic Name albendazole mirtazapine lispro irinotecan HCl nevirapine meropenen cidofovir remifentanil HCl fexofenadine HCl fosphenytion sodium bentoquatam...
author: Carolyn Spencer
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RLD_LABELING_APPROVED_OCT_1999
Reference Listed Drug Labeling Approved in October 1999 Some of the product names below contain links to the approved labeling or the supplemental approval letter describing the specific changes.- Click on the product name to view the approved labeling changes in Adobe Acrobat format
Supp.No
19-011 S-013 Braintree Labs 7-Oct-1999 NuLYTELY PEG-3350,NaCl,NaHCO3,KCl for oral sol...
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Geodon Consumer Information
Therefore do not take Geodon if you have the following heart conditions:- long QT syndrome (a specific heart rhythm problem)- a recent heart attack- severe heart failure- certain irregularities of heart rhythm (discuss the specifics with your doctor)- Do not take Geodon if you are currently taking medications that should not be taken while you are taking Geodon, such as:- dofetilide ...
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http://www.fda.gov/cder/foi/label/2002/20677s4lbl.pdf
Patient Information About: Zagama a (sparfloxacin) 200 mg Tablets This section contains important information about Zagam (sparfloxacin), and should be read completely before you begin treatment
If you have any questions about Zagam talk with your health care professional
Zagam Tablets are white and contain 200 mg of active drug
How and When...
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http://www.fda.gov/cder/foi/label/2002/20677s4lbl.pdf page 1
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Abstract for Molecular Devices Meeting at Half Moon Bay
Arthur Brown, Ph. D. Ion Channels in Drug Safety and Drug Discovery A major contemporary problem in drug safety testing is QT prolongation. QT prolongation may be accompanied by a polymorphic ventricular tachycardia (VT) called torsade de pointes (TdP) that may in turn lead to ventricular fibrillation ...
author: ABrown
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Prescription and OTC Drug Product List 8/1998
Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 8: August 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL - ADD - BUTALBITAL, ACETAMINOPHEN AND CAFFEINE MODURETIC 5-50 - ADD - AB MALLINCKRODT...
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http://www.emea.eu.int/pdfs/human/phv/EN/083595en.pdf
The European Agency for the Evaluation of Medicinal Products 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Switchboard: (+ 44- 171) 418 8400 Fax: (+ 44- 171) 418 8551 E_ Mail: mail@ emea. eudra. org http:// www. eudra. org/ emea. html CPMP/ 835/ 95 FINAL OPINION OF THE COMMITTEE FOR PROPRIETARY ...
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http://www.emea.eu.int/pdfs/human/phv/EN/083595en.pdf page 3
2/ 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME of the MEDICINAL PRODUCT ZAGAM (sparfloxacin) 200 mg 2. QUALITATIVE and QUANTITATIVE COMPOSITION Sparfloxacin 200 mg 3. PHARMACEUTICAL FORM White film- coated tablets for oral use. The tablets are marked on one face with RPR201. 4. CLINICAL PARTICULARS ...
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http://www.emea.eu.int/pdfs/human/phv/EN/083595en.pdf page 1
The European Agency for the Evaluation of Medicinal Products 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Switchboard: (+ 44- 171) 418 8400 Fax: (+ 44- 171) 418 8551 E_ Mail: mail@ emea. eudra. org http:// www. eudra. org/ emea. html CPMP/ 835/ 95 FINAL OPINION OF THE COMMITTEE FOR PROPRIETARY ...
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http://www.emea.eu.int/pdfs/human/phv/EN/093195en.pdf
The European Agency for the Evaluation of Medicinal Products 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Switchboard: (+ 44- 171) 418 8400 Fax: (+ 44- 171) 418 8551 E_ Mail: mail@ emea. eudra. org http:// www. eudra. org/ emea. html CPMP/ 931/ 95 FINAL OPINION OF THE COMMITTEE FOR PROPRIETARY ...
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http://www.emea.eu.int/pdfs/human/phv/EN/093195en.pdf page 2
formulated under Article 12 of Council Directive 1 75/ 319/ EEC of 20 May 1975 The Committee considered the referral made under Article 12 of Council Directive 75/ 319/ EEC for ZAGAM 100 mg (Sparfloxacin). The Committee agreed on very restricted indications for Sparfloxacin following an evaluation ...
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http://www.emea.eu.int/pdfs/human/phv/EN/093195en.pdf page 1
The European Agency for the Evaluation of Medicinal Products 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Switchboard: (+ 44- 171) 418 8400 Fax: (+ 44- 171) 418 8551 E_ Mail: mail@ emea. eudra. org http:// www. eudra. org/ emea. html CPMP/ 931/ 95 FINAL OPINION OF THE COMMITTEE FOR PROPRIETARY ...
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http://www.emea.eu.int/pdfs/human/phv/Sparfloxacin.pdf
The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Switchboard: (+ 44- 171) 418 8400 Fax: (+ 44- 171) 418 8551 E_ Mail: mail@ emea. eudra. org http:// www. eudra. org/ emea. html London, 3 April, 1997 CPMP/ ...
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FDA Drug Approvals List October 1999
Application #: 020156 Efficacy Supplement#: 022 Type: SE2 to Original New Drug Application Approval Date: 28-OCT-99 Trade Name: VIDEX Dosage Form: POWDER, FOR RECONSTITUTION Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): DIDANOSINE OTC/RX Status: RX Efficacy Claim:Provides for a new strength as well as allowing a change in dosing interval...
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Drug Approvals December 1996
Drug Approvals for December 1996 Definitions and Notes December 1996 Original New Drug Applications Original Application #: 020681 Approval Date: 31-DEC-96 Trade Name: ORTHO TRI-CYCLEN Chemical Type: 6 Therapeutic Potential: S Dosage Form: TABLET Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP Active Ingredient(s): ETHINYL ESTRADIOL; NORGESTIMATE...
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Reference Listed Drug Labeling Approved in October 2002
Oct 1 THYROLAR-3 letter label liotrix tablets 16-807 SLR 025 Oct 1 VUMON letter label teniposide for injection 20-119 SLR 004 Oct 2 PAXIL letter label paroxetine HCl tablets 20-031 SE8 035 Oct 2 WELLBUTRIN letter label bupropion HCl tablets 18-644 SLR 024 Oct 2 WELLBUTRIN SR letter label bupropion HCl extended-release tablets 20-358 SLR 024 Oct 2 ZAGAM letter label sparfooxacin...
author: USERNAME
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http://www.fda.gov/cder/foi/label/2002/20677s4lbl.pdf page 3
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http://www.fda.gov/cder/foi/label/2002/20677s4lbl.pdf page 2
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