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Drug Approvals - A NDA 19-885/S-018 4/17/01 5/3/01 - 12/24/03 Accuretic Tablets, Rx -Parke-Davis NDA 20-125 12/28/99 1/3/00 1/3/00 5/31/01 - Accuretic Indication:Treatment of hypertension Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mgisotretinoin) Capsules, 10 mg, 20 mg, and 40 mg
Office of Drug Safety: Patient Labeling and Risk Communitation Food and Drug Administration • Center for Drug Evaluation and Research Office of Drug Safety Search Patient Labeling and Risk Communication FDA-Approved Patient Labeling Patient Package Inserts.- For some prescription medicines, FDA approves special patient materials to instruct patients about the safe use of the product
author: PhillipsJ
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,...
2003 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 2003 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office
author: STAUFFERP
CDER Report to the Nation: 2002; Drug Safety and Quality Food and Drug Administration • Center for Drug Evaluation and Research About CDER - Report Search CDER Report to the Nation: 2002 Table of Contents Adobe Acrobat version of this document Drug Safety and Quality Index Mission Highlights Types of Risks from Medicines Drug Safety MedWatch Outreach and Reporting Medication Guides Drug Shortages Drug Recalls and Withdrawals Recalls...
author: OLIVERN
Prescription and OTC Drug Product List 11/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 325MG;5MG N40478 001 NOV 08, 2002 NOV NEWA -A- AA 500MG;10MG N40473 001 NOV 06, 2002 NOV NEWA -A- AA 500MG;5MG N40477 001 NOV 06, 2002 NOV NEWA AMCINONIDE LOTION; TOPICAL -A- AMCINONIDE -A- AB ALTANA 0.1% N76329 001 NOV 06, 2002 NOV NEWA CYCLOCORT -D- + FUJISAWA...
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News | News/Media | Cardinal Health #query { height:12px; line-height:12px; color:#999999; width:100%; } #Flag { margin: -4px 0 3px; } Contact us -|- Sign in -|- U.S.A.Amnesteem .
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CardinalHealth 2003 Online AR | Chairman’s Letter At a Glance | Chairman’s Letter | Jill’s Story | Proprietary Offerings | Integrated Solutions | Expertise The year ended June 30, 2003, was the 20th fiscal year since our public offering.
CardinalHealth 2003 Online AR | Corporate & Investor Info At a Glance | Chairman’s Letter | Jill’s Story | Proprietary Offerings | Integrated Solutions | Expertise Corporate office Cardinal Health 7000 Cardinal Place Dublin, Ohio 43017 (614) 757-5000 www.cardinal.com Common shares Cardinal Health’s common shares are listed on the New York Stock Exchange under the ticker symbol “CAH,” and is a component of the...
http://www.roche.com/pages/downloads/investor/pdf/praesentations/irphy230703chp.pdf 2 Roche First half 2003 Presentation to analysts Basle, Zurich, New YorkAmnesteem Sotret Claravis data source: IMS NPA prescription data
http://www.roche.com/pages/downloads/investor/pdf/praesentations/irphy230703ch.pdf 2 Roche First half 2003 Presentation to analysts Basle, Zurich, New YorkAmnesteem Sotret Claravis data source: IMS NPA prescription data
DOCUMENT INFORMATION PAGE Unsubstantiated Efficacy Claims and Minimization of Risk The statements "because of the way it can affect your self- esteem, acne can cause emotional scars" and "if your acne is the source of an unusual amount of worry or stress, you might want to see a dermatologist," combined with the prominent logo for Amnesteem heading the page and the title "More than skin deep," suggest...
author: CDER USER
DOCUMENT INFORMATION PAGE page 3
author: CDER USER
DOCUMENT INFORMATION PAGE page 2
author: CDER USER
http://www.cardinal.com/content/investor/releases/financials/033103.pdf FOR IMMEDIATE RELEASE Contacts: David Verbraska – Media (614) 757- 3690 Steve Fischbach – Investors (614) 757- 7067 CARDINAL HEALTH REPORTS RECORD THIRD QUARTER REVENUES AND EARNINGS DUBLIN, Ohio, April 23, 2003– Cardinal Health, Inc
http://www.cardinal.com/content/investor/releases/financials/033103.pdf page 4
