Pediatric Advisor 2004.2: Theophylline Pediatric Health Topics | All Health Topics Mott Children's Hospital | Pediatric Services Find a UMHS Doctor Search Pediatric Topics Search All Topics This information is approved and/or reviewed by U-M Health System providers but it is not a tool for self-diagnosis or a substitute for medical treatment.Extended Release ...
Drug Approvals - B Biaxin Filmtab and Biaxin® Granules,- Abbott Laboratories NDA 50-697/S2 & 50-698/S14 5/24/02 6/17/02 - - BIAXIN XL Tablets (clarithromycin extended-release) Abbott Laboratories NDA 50-775 3/3/00 3/7/00 3/7/00 10/11/01 BIAXIN XL Filmtab (clarithromycin) Extended -release Tablets, 500 mg, Rx Abbott Laboratories NDA 50-775/S4 4/11/03 4/18/03 &n; bsp; - BIAXIN XL...
Drug Approvals - N ANDA 75-416/S2, S3 4/23/03 - - - Naproxen Sodium Extended -release Tablets, 500 mg, Rx Andrx Pharmaceuticals, Incclarithromycin and amoxicillin for the eradication of Helicobacter pylori in patients with duodenal ulcer disease or- a history of duodenal ulcer diseaseExtended -Release Tablets, 500 & 750mg, Rx...
Patent and Exclusivity Terms HEPATITIS C U-376 TREATMENT OF INFLUENZA U-377 METHOD OF TREATING PT WITH CHRONIC HEPATITIS C HAVING HCV GENOTYPE 1 AND VIRAL LOAD GREATER THAN 2 MILLION COPIES/ML TO ERADICATE DETECTABLE HCV-RNA BY ADMIN COMBINATION OF RIBAVIRIN AND INTERFERON ALFA-2B FOR A LEAST 24 WEEKS U-378 METHOD FOR TREATING INCONTINENCE U-379 METHOD OF TREATING ONYCHROMYCOSIS U-380 COMBINATIONS OF TAXOL ...
1997 Warning Letters and Notice of Violation Letters to Pharmaceutical Companies Johnson DDMAC 9/24/1997 5/29/1998 Posicor (Mibefradil Dihyrdrochloride) Tablets Hoffman-La Roche DDMAC 9/5/1997 5/29/1998 Salagen (Pilo carpine HCl) MGI Pharma DDMAC 9/24/1997 5/29/1998 Site Inspection Gedeon Richter, Ltd DMPQ 9/5/1997 9/24/1997 Zocor (Simvastatin) Merck DDMAC 9/22/1997 5/29/1998 October 1997 Accolate (Zafirkulast) Tablets Zeneca Pharmaceuticals DDMAC 10/1/1997 5/22...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt IN TAMAQUA, PA" 10812 15-Mar-94 WYCKOFF CHEMICAL CO INC "MACA (5-METHANESULFONYLAMINOINDOLE-2-CARBOXYLIC ACID) MANUFACTURED IN SOUTH HAVEN, MICHIGAN" 10817 15-Mar-94 BACHEM FEINCHEMIKALIEN AG "1-HYDROXY-2-NAPHTHOYL-ARG-PRO-NH2 HYDROCHLORIDE MANUFACTURED IN BUBENDORF, SWITZERLAND" 10823 18-Mar-94 EMS-DOTTIKON AG "ISOSORBIDE-5-NITRATE EXTENDED RELEASE PREMIXTURE 49.2%...
50775S1_Biaxin Filmtabs Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Biaxin XL Filmtab (Clarithromycin) Extended -Release Tablets Company:--Abbott Laboratories Application No.:--50-775S1 Approval Date:-10/20/2000 - Approval Letter(s) - Printed Labeling - Medical Review(s) Part 1 - Part 2 - Statistical Review(s) - Microbiology Review(s)...
author: Paul Stauffer
50755_BiaxinXL.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Biaxin XL Filmtab (Clarithromycin Extended Release Tablets) Company:--Abbott Laboratories Application No.:--50-775 Approval Date:-3/3/2001 - Approval Letter(s) - Printed Labeling - Medical Review(s) Part 1 - Part 2 - Part 3 - Part 4 - Chemistry Review(s) - Statistical...
author: Paul Stauffer
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004 - INJECTION Approved 8/13/2003- METHADONE HYDROCHLORIDE 15MG,20MG,30MG,40MG - 03P-0119/CP1 LACHMAN CONSULTANT SERVICES - TABLETS USP Pending 5/13/2003- VENLAFAXINE HYDROCHLORIDE 37.5MG, 75MG, 150MG - 03P-0159/CP1 LACHMAN CONSULTANT SERVICES - EXTENDED RELEASE TABLETS Pending 4/16/2003- DIVALPROEX SODIUM 1000 MG - 03P-0178/CP1 LACHMAN CONSULTANT SERVICES - EXTENDED ...
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004 - INJECTION Denied 8/1/2001- CLARITHROMYCIN 1000 MG - 03P-0238/CP1 THE WEINBERG GROUP - EXTENDED -RELEASE TABLETS Approved 12/18/2003- CLONAZEPAM 1 MG/5 ML - 03P-0464/CP1 LACHMAN CONSULTANT SERVICES - ORAL SOLUTION Pending 10/2/2003- CLOZAPINE 12.5 MG - 99P-1267/CP1 LACHMAN CONSULTANT SERVICES - TABLET;ORAL Approved 2/17/2000- CLOZAPINE 200 MG - 99P-1268/CP1 LACHMAN...
Microsoft Word - ASL - 01 Autosub List.doc Drops Biaxin® (RS – 30) use in pneumonia 250 – 500mg bid Zithromax®; unless meets RS – 30 criteria 500 mg then 250mg od on day 1 od X 4 days calcium carbonate Lowest Cost Alternative Cascara® Senokot® clarithromycin (Biaxin®) (RS – 30) use in pneumonia 250 – 500 mg bid azithromycin (Zithromax®); unless meets RS – 30...
author: Wendy Daws
http://www.phrma.org/newmedicines/resources/2003-11-23.120.pdf Triangle Park, NC Mycobutin ® Pharmacia MAC prophylaxis in patients with advanced HIV infection rifabutin Peapack, NJ NebuPent ® Fujisawa Healthcare PCP prophylaxis aerosol Deerfield, IL pentamidine isethionate Neutrexin MedImmune Oncology treatment of moderate- to- severe PCP in immunocompromised trimetrexate Gaithersburg, MD patients, including patients with AIDS, who are...
Prescription and Over-the-Counter Drug Product List: 5/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
1151-0316 DitropanXLr1 have demonstrated that oxybutynin increases bladder (vesical) capacity, diminishes the frequency of uninhibited contractions of the detrusor muscle, and delays the initial desire to voidExtended Release Tablets DESCRIPTION DITROPAN XL ® (oxybutynin chloride) is an antispasmodic, anticholinergic agent
author: Jenny Levallius
C:\Data\Altocor-N21316\AP.SLR006.doc NDA 21- 316/ S- 006 Page 3 ALTOCOR EXTENDED - RELEASE TABLETS (LOVASTATIN) DESCRIPTION ALTOCOR (Lovastatin) Extended - Release Tablets contain a cholesterol- lowering agent isolated from a strain of Aspergillus terreusExtended - Release Tablets are designed for once- a- day oral administration and deliver 10 mg, 20 mg, 40 mg, or 60 mg of...
author: Valerie Jimenez
C:\Data\Altocor-N21316\AP.SLR006.doc page 21
author: Valerie Jimenez
http://www.phrma.org/newmedicines/resources/2002-12-05.98.pdf Triangle Park, NC Mycobutin ® Pharmacia MAC prophylaxis in patients with advanced HIV infection rifabutin Peapack, NJ NebuPent ® Fujisawa Healthcare PCP prophylaxis aerosol Deerfield, IL pentamidine isethionate Neutrexin MedImmune Oncology treatment of moderate- to- severe PCP in immunocompromised trimetrexate Gaithersburg, MD patients, including patients with AIDS, who are...
http://www.fda.gov/cder/pediatric/labels/Oxybutynin.pdf Logo NDA 20- 897: DITROPAN XL ® (oxybutynin chloride) Extended Release Tablets – Revised Final Draft (Submitted April 3, 2003) 1 DITROPAN XL (oxybutynin chloride) Extended Release Tablets DESCRIPTION DITROPAN XL ® (oxybutynin chloride) is an antispasmodic, anticholinergic agentExtended ...
http://www.fda.gov/cder/pediatric/labels/Oxybutynin.pdf page 18
duplicates:http://www.fda.gov/cder/foi/label/2003/17577se8-033,18211se8-016,20897slr010_ditropan_lbl.pdf
FDA Drug Approvals List August 2001 - Drug Approvals for August 2001 Definitions and Notes Original New Drug Applications Original Application #: 021222 Approval Date: 29-AUG-01 Trade Name: SPECTRACEF Chemical Type: 1 Therapeutic Potential: S Dosage Form: TABLET Applicant: TAP PHARMACEUTICAL PRODUCTS INC Active Ingredient(s): CEFDITOREN PIVOXIL OTC/RX Status: RX Indication(s): For the treatment of acute bacterial...
FDA Drug Approvals List February 2001 - Drug Approvals for February 2001 Definitions and Notes Original New Drug Applications Original Application #: 021169 Approval Date: 28-FEB-01 Trade Name: REMINYL Chemical Type: 1 Therapeutic Potential: S Dosage Form: TABLET Applicant: JANSSEN RESEARCH FDN Active Ingredient(s): GALANTAMINE HYDROBROMIDE OTC/RX Status: RX Indication(s): For the treatment of mild to moderate dementia...
FDA Drug Approvals List June 2002 - Drug Approvals for June 2002 Definitions and Notes Original New Drug Applications Original Application # 021316 Approval Date: 26-JUN-02 Trade Name: ALTOCOR Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: AURA LABORATORIES INC Active Ingredient(s): LOVASTATIN OTC/RX Status: RX INDICATION OF USE: For lowering total cholesterol and LDL-C to target levels as...
FDA Drug Approvals List May 2002 - Drug Approvals for May 2002 Definitions and Notes Original New Drug Applications Original Abbreviated Antibiotic Application # 065082 Approval Date: 31-MAY-02 Trade Name: CEFPODOXIME PROXETIL Dosage Form: GRANULE, FOR RECONSTITUTION Applicant: RANBAXY LABORATORIES LTD Active Ingredient(s): CEFPODOXIME PROXETIL OTC/RX Status: RX Original Application #: 021292 Approval Date: 31-MAY...
Prescription and OTC Drug Product List 6/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA PEACHTREE 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN -A- AA UCB 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE TABLET; ORAL DARVOCET -A- @ AAIPHARMA LLC 325MG;32.5MG N16844 001 JUN CAHN -D- @...
510(k)s Final Decisions Rendered for July 2000 510(k) NO: K000869 (TRADITIONAL) ATTN: GARY DARLING PHONE NO : 501-636-5776 115 EAST LINDEN SE DECISION MADE: 19-JUL-00 ROGERS, AR 72756 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING ATL ULTRASOUND, INC
author: CDRH/ODE
