Drug Approvals - O Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Ocufen Ophthalmic Solution, (0.03%) Allergan NDA 19-404/S020 8/25/03 8/28/03 8/28/03 - Ocufen Ophthalmic Solution (0.03%) Allergan NDA 19-404/S017 8/17/01 - 4/15/03 - Ocufen Ophthalmic Solution (0.03%) Allergan NDA 19-404/S014 7/30/01 - 4/15/03 - Ofloxacin Injection, 40 mg/mL packaged in 10 mL...
Prescription and Over-the-Counter Drug Product List: 12/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> + MIKART 750MG;50MG;40MG N40496 001 DEC 23, 2003 DEC NEWA ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE TABLET; ORAL DARVOCET A500 >D> + AAIPHARMA 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA >A> + 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA...
http://www.fda.gov/cder/orange/appendix_a.txt IRRIGANT, NEOMYCIN SULFATE NEOSPORIN, BACITRACIN ZINC NEOSPORIN, GRAMICIDIN NEOSPORIN, NEOMYCIN SULFATE (OTC) NEOTHYLLINE, DYPHYLLINE NEOTRIZINE, TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE; SULFAMETHAZINE) NEPHRAMINE 5.4%, AMINO ACIDS NEPHROFLOW, IODOHIPPURATE SODIUM, I-123 NEPTAZANE, METHAZOLAMIDE NESACAINE, CHLOROPROCAINE HYDROCHLORIDE NESACAINE-MPF, CHLOROPROCAINE...
NDA Approvals for Calendar Year 2003 NDA APPROVALS FOR CALENDAR YEAR 2003 Updated through December 31, 2003 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21434 Xanax XR Alprazolam Pharmacia and Upjohn FR 3 S 17-Jan-03 21305 Sodium Iodide I-131 Sodium Iodide I-131 DraxImage 3,5 S 24-Jan-03 20414 Pyridostigmine Bromide Pyridostigmine Bromide US Army 3 P 05-Feb-03...
author: Susan Daugherty
C:\Active files-Documents\NDAs\n 21-451 oraqix\N 21-451 AP ltr 12-18\ -03.doc Modric: Please refer to your new drug application (NDA) dated January 22, 2002, received January 22, 2002, submitted under section 505( b) of the Federal Food, Drug, and Cosmetic Act for Oraqix (Lidocaine and prilocaine periodontal gel) 2.5%/ 2.5%Oraqix (Lidocaine and prilocaine periodontal gel) 2.5%/ 2.5%...
author: Kimberly Compton
C:\Active files-Documents\NDAs\n 21-451 oraqix\N 21-451 AP ltr 12-18\ -03.doc page 1
author: Kimberly Compton
Bioniche February 12, 2008 Bioniche Reports Fiscal 2008 Second Quarter February 8, 2008 Bioniche Receives $5 Million Capital Financing Support to Scale-up E.Lidocaine -Prilocaine Spray.
Bioniche February 12, 2008 Bioniche Reports Fiscal 2008 Second Quarter February 8, 2008 Bioniche Receives $5 Million Capital Financing Support to Scale-up E.
AstraZeneca International - pharmaceutical company, prescription drugs, medicine manufacturers Skip to content Home Media Investors Careers Products Licensing Research Responsibility About us Contact us - - EMLA (Eutectic Mixture of Lidocaine and Prilocaine) EMLA (Eutectic Mixture of Lidocaine and Prilocaine) is a local anaesthetic for topical application, developed to anaesthetise intact skin.
AstraZeneca International - pharmaceutical company, prescription drugs, medicine manufacturers Skip to content Home Media Investors Careers Products Licensing Research Responsibility About us Contact us - - Neuroscience Health problems related to the function of the nervous system, including the brain, are a complex area of significant medical need that touches many people's lives.
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.
EMLA (Eutectic Mixture of Lidocaine and Prilocaine) - AstraZeneca 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 - -Neuroscience - - EMLA (Eutectic Mixture of Lidocaine and Prilocaine) EMLA (Eutectic Mixture of Lidocaine and Prilocaine) is a local anaesthetic for topical...
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.
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.
AstraZeneca Products - Neuroscience - Schizophrenia, central nervous system, migraine treatments 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 - -Neuroscience - - Neuroscience Health problems related to the function of the central nervous system, including the brain, are a complex area of significant...
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.
Microsoft Word - RPSepicPOM A Aciclovir 6 Acrivastine 6 Aluminium chloride 6 Aspirin 8, 46 Astemizole 5 Atropine Sulphate 9 Azelastine 8, B Beclomethasone Dipropionate 6, 47 Benzocaine 47 Benzoyl Peroxide 46 Budesonide 8 C Cadexomer- Iodine 8 Camphor 47 Carbenoxolone 6 Cetirizine 6,47 Cimetidine 6 Chloramphenicol 9 Clobetasone 9 Clotrimazole 6,8,46 Co- methiamol 29 D Dequalinium chloride 46 Dextranomer 5...
Specificity Table TOX.xls Tested (ng/ ml) Chlor- Trimeton Chlorpheniramine Antihistamine 100,000 Chocolax Phenolphthalein Laxative 100,000 Cholesterol Cholesterol Emulsifying agent 100,000 Cibazol Sulfathiazole Antibacterial 100,000 Cinchovatine Cinchonidine Antimalarial 100,000 Cinobal Cinoxacin Antibacterial 100,000 Cipro Ciprofloxacin Antibacterial 100,000 Citanest Prilocaine Anesthetic 200,000...
author: Biosite Incorporated
http://www.adis.com/files/newsletters/REA/RxCov1003.pdf Nilutamide: fatal hepatitis 11 Morphine to be used with caution in preterm neonates 3 Olanzapine: diabetic ketoacidosis [S] 11 NSAIDs: prevention of GI events inadequate 5 Pivmecillinam: interaction with concomitant valproic acid 14 Sodium bicarbonate treatment of choice before contrast 5 leading to hyperammonaemic encephalopathy [ X S] exposure Prilocaine/ lidocaine overdose:...
1998 Warning Letters and Untitled Letters to Pharmaceutical Companies Food and Drug Administration • Center for Drug Evaluation and Research Compliance Activities Search Warning Letters and Untitled Letters to Pharmaceutical Companies 1998 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt "NIZATIDINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 14038 19-Mar-99 LEO PHARMACEUTICAL PRODUCTS LTD "HEPARIN SODIUM DRUG SUBSTANCE AS MANUFACTURED IN ESBJERG, DENMARK, MIDDLESBROUGH, UNITED KINGDOM, AND CORK, IRELAND" 14039 19-Mar-99 LEO PHARMACEUTICAL PRODUCTS LTD "HEPARINASE DRUG SUBSTANCE AS MANUFACTURED IN BALLERUP, DENMARK" 14040 11-Mar-99 TEVA GROUP "MUPIROCIN AS...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls ACETOHEXAMIDE MFG.PAULLO(MILANO)FACILITY ON VIA CURIEL(WAS LIDOCAINE) DIOSYNTH BV ESTRADIOL MICRONIZED PHARMACIA AND UPJOHN COMPANY NICORETTE (R): PRODUCTION OF CHEWING GUM AT THE ESBJERG, DENMARK PLANT PHARMACIA AND UPJOHN COMPANY NICORETTE (R) CHEWING GUM DIOSYNTH BV HYDROXYPROGESTERONE CAPROATE LONZA INC DEXTROMETHOPHAN HYDROBROMIDE AS MFG
ANDA Approvals - September 2003 - FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Approvals - September 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 76-220 OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG - RANBAXY LABORATORIES LIMITED 9/2/2003- 2 76-093 OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG - PAR PHARMACEUTICAL, INC
Prescription and Over-the-Counter Drug Product List: 9/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> + MIKART 325MG/15ML;7.5MG/15ML N40482 001 SEP 25, 2003 SEP NEWA ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET; ORAL >A> OXYCODONE AND ACETAMINOPHEN >A> AA WATSON LABS 325MG;7.5MG N40535 001 SEP 05, 2003 SEP NEWA >A> AA 325MG;10MG...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 8/2003 4 >D> AA + ORTHO MCNEIL PHARM 300MG;60MG N85055 004 AUG DISC >A> @ 300MG;60MG N85055 004 AUG DISC ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA + MALLINCKRODT 500MG/15ML;10MG/15ML N40508 001 AUG 29, 2003 AUG NEWA >D> MIKART 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG CTEC >A> AA 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG...
author: AUTHOR
