Medicis.com | The Dermatology Company -About Medicis Business Development Careers Investor Relations Products R&D Governance Site Map - Medicis, The Dermatology Company ® Dynacin ® (minocycline HCl) The number one branded minocycline among dermatologists.
Antibiotics for sinusitis - [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 Antibiotics for sinusitis - [Medication] - Quest Diagnostics Patient Health Library Antibiotics for sinusitis - [Medication] - Quest Diagnostics Patient Health Library Amoxicillin, amoxicillin with clavulanate, amoxicillin with clavulanate potassium,...
Antibiotics for sinusitis - [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 Antibiotics for sinusitis - [Medication] - Quest Diagnostics Patient Health Library Antibiotics for sinusitis - [Medication] - Quest Diagnostics Patient Health Library Amoxicillin, amoxicillin with clavulanate, amoxicillin with clavulanate potassium,...
Drug Approvals - O ANDA 75-347 3/23/00 3/31/00 - - Omnicef (cefdinir) Capsules,- Abbott Laboratories NDA 50-739/S-006 7/24/02 8/6/02 Omnicef (cefdinir) Capsules,- Parke-Davis NDA 50-739/S-002 11/24/99 12/30/99 12/30/99 - Omnicef (cefdinir) Powder Oral Suspension Parke-Davis NDA 50-749/SE2-002 7/14/99 7/29/99 7/29/99 - - Omnicef Indication: 5-day dosing regimen ...
Dow Pharmaceutical Sciences - Show News Topical Formulations Skin Biology Analytical Stability Topicals Manufacturing Clinical Labeling Regulatory/Clinical Affairs Solano Clinical Research Company Mission Management Department Heads Tour -- Thursday, February 12 -- Back to News September 26, 2002 - - FOR IMMEDIATE RELEASE - - CONTACT: - Medicis, Scottsdale, Arizona - Libby Ivy, Executive Director, Investor Relations &...
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...
Reference Listed Drug Labeling Approved in June 2002 PEDIATRIC letter label multi-vitamins injection 18-920 SLR 024 --- TAXOTERE letter --- docetaxel injection 20-449 SLR 017 Jul 11 GLUCAGEN letter --- glucagon (rDNA origin) injection 20-918 SLR 003 ACTOS letter label pioglitazone tablet 21-073 SE8 010 --- AREDIA letter --- pamidronate disodium injection 20-036 SE8 026 Jul 12 HABITROL letter label nicotine transdermal system 20-076 SLR...
author: USERNAME
1997 New Drug Application (NDA) New Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
RLD_LABELING_APPROVED_JUL_1999 Supp.No Firm Date VIDEX Didanosine chewable tablets 20-154 S-028 Bristol Myers Squibb 01-Jul-1999 VIDEX Didanosine for oral solution 20-155 S-020 Bristol Myers Squibb 01-Jul-1999 ZERIT Stavudine capsules 20-412 S-010 Bristol Myers Squibb 01-Jul-1999 ZERIT Stavudine oral solution 20-413 S-003 Bristol Myers Squibb 01-Jul-1999 CAVERJECT Alprostadil for injection 20-379 S-012 Pharmacia &...
FDA Drug Approvals List July 2002 45 Dosage Form: INJECTABLE Applicant: XCEL PHARMACEUTICALS Active Ingredient(s): DIHYDROERGOTAMINE MESYLATE OTC/RX Status: RX Application #: 020449 Labeling Supplement #: 019 To Original New Drug Application Approval Date: 30-JUL-02 Trade Name: TAXOTERE Dosage Form: INJECTABLE Applicant: AVENTIS PHARMACEUTICALS INC Active Ingredient(s): DOCETAXEL OTC/RX Status: RX Application #:...
http://www.fujisawa.co.jp/ir/ar2003/2003p2.pdf Millions of yen 2003 2002 2001 2000 1999 Results for the year: Net sales ¥ 382,079 ¥341,356 ¥297,517 ¥289,142 ¥277,281 Research and development expenses ...........cefdinir) and the antihypertensive Nivadil® (nilvadipine) declined
http://www.fujisawa.co.jp/ir/ar2003/2003p2.pdf page 2
Fujisawa Pharmaceutical Co., Ltd. Fujisawa's core business is its line of ethical pharmaceutical products, accounting for approximately 90 % of net sales
http://www.fujisawa.co.jp/ir/ar2003/2003h_1.pdf ANNUAL REPORT 2003 1 Fujisawa Pharmaceutical Co., Ltd., headquartered in Japan, is a research- driven pharmaceutical company with a firm commitment to innovative research in its quest to satisfy unmet medical needs and contribute to the progress of medical care
http://www.fujisawa.co.jp/english/ir/pdf/ar2002/data/f_2002p2.pdf Millions of yen 2002 2001 2000 1999 1998 Results for the year: Net sales ¥341,356 ¥297,517 ¥289,142 ¥277,281 ¥281,584 Research and development expenses ........cefdinir)
V:\DAIDP\PEAT\Approval Letter\50739.doc DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 NDA 50- 739/ S- 006 Abbott Laboratories Attention: Alexa Chun, PhOmnicef (...
author: Raquel Peat
V:\DAIDP\PEAT\Approval Letter\50739.doc page 1
author: Raquel Peat
Fujisawa Pharmaceutical Co., Ltd. Fujisawa Pharmaceutical Co., Ltdcefdinir, has made a valuable contribution to infectious disease therapy worldwide and thus reinforced Fujisawa's strong reputation as a leading cephalosporin company
author: D&join
Prescription and OTC Drug Product List 1/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 1: January 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST PRESCRIPTION DRUG PRODUCT LIST 1 20TH EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / JAN'2000 - ADD - CALCIUM CHLORIDE CEFTIBUTEN DIHYDRATE - ADD -...
http://www.fda.gov/cder/foi/label/1999/50739S2LBL.PDF OmnicefO (cefdinir) sNDA 50- 739 DM_ FILE/ CI- 983 (GLW29299g) 17 In the US, the following adverse events were thought by investigators to be possibly, probably, or definitely related to cefdinir capsules in multiple- dose clinical trials (N = 3841 cefdinir - treated patients): ADVERSE EVENTS ASSOCIATED WITH CEFDINIR CAPSULES US TRIALS IN ADULT AND ADOLESCENT...
http://www.fda.gov/cder/foi/label/1999/50739S2LBL.PDF page 25
http://www.fda.gov/cder/foi/label/1999/50739S2LBL.PDF page 23
http://www.fda.gov/cder/foi/label/1999/50739S2LBL.PDF page 22
http://www.fda.gov/cder/foi/label/1999/50739S2LBL.PDF page 19
http://www.fda.gov/cder/foi/label/1999/50739S2LBL.PDF page 16
