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...
CDER Template - Replace Title Here Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - June 2002 - Generic Drug Name Generic Manufacturer Brand Name Approval Date- 1- AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, U 200 MG/28.5 MG (BASE)/5 ML, AND 400 MG/57 MG (BASE)/5 ML GENEVA PHARMACEUTICALS, INC
author: USERNAME
First-Time Generics - July 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - July 2002 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG TEVA PHARMACEUTICALS USA PRINIZIDE TABLETS 7/1/02 2 LISINOPRIL TABLETS, USP 2.5 MG, 5 MG,--------...
author: OGD
Prescription and OTC Drug Product List 8/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -A- AA ABLE 300MG;30MG N40452 001 AUG 01, 2002 AUG NEWA -A- AA 300MG;60MG N40459 001 AUG 01, 2002 AUG NEWA ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE TABLET; ORAL ACETAMINOPHEN AND PENTAZOCINE HCL -A- AB AMIDE PHARM 650MG;EQ 25MG BASE N76202 001...
Prescription and OTC Drug Product List 6/2002 -D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
January 23, 2002 page 1
author: Alpharma Inc.
Drug Approvals November 1996 Drug Approvals for November 1996 Definitions and Notes November 1996 Original New Drug Applications Original Application #: 020397 Approval Date: 27-NOV-96 Trade Name: ZANAFLEX Chemical Type: 1 Therapeutic Potential: S Dosage Form: TABLET Applicant: ATHENA NEUROSCIENCES INC Active Ingredient(s): TIZANIDINE HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the acute...
Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Release Teva Announces Approval of Tizanidine HCl Tablets Jerusalem, Israel, July 3, 2002 - Teva Pharmaceutical Industries Ltd.Tizanidine HCl Tablets, 2 mg and 4 mg.Tizanidine HCl Tablets are the AB-rated generic equivalent of Elan Pharmaceuticals ...
2002 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 2002 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information OfficeZanaflex (Tizanidine HCL) tablets Elan Pharmaceuticals DDMAC 8/5/2002 9/4...
author: STAUFFERP
C:\My Documents\Tizan_caps.nda\2AP_let_lbl.doc Tizanidine 's molecular formula is C9H8CIN5S- HCl, its molecular weight is 290.2 and its structural formula is: Zanaflex is supplied as 2 and 4 mg tablets and 2, 4, and 6 mg capsules for oral administrationTizanidine has not been evaluated in children (see PRECAUTIONS)Tizanidine is an 2- adrenergic agonist (like clonidine) and can produce...
author: Lana Chen
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author: Lana Chen
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author: Lana Chen
News & PR - TEVA Pharmaceutical Industries Ltd TEVA ANNOUNCES APPROVAL OF TIZANIDINE HCl TABLETS Jerusalem, Israel, July 3, 2002 - Teva Pharmaceutical Industries LtdTizanidine HCl Tablets, 2 mg and 4 mgTizanidine HCl Tablets are the AB-rated generic equivalent of Elan Pharmaceuticals Zanaflex ® Tablets which are indicated for...
Spinal Cord Injury Clinical Research Report Paratracks, November 2000. Publication of Canadian Paraplegic Association (Manitoba) Inc. RESEARCH Spinal Cord Injury Clinical Research Report by Orpha Schryvers I believe a short explanation is needed, before reading about the following research projects. In clinical research, basic researchers ...
author: Orpha Schryvers
Prescription and Over-the-Counter Drug Product List: 1/2004 ADULT >A> + AAIPHARMA LLC 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL ;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL; 40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/V IAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL N21625 001 JAN 30, 2004 JAN NEWA BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED; TOPICAL BETAMETHASONE DIPROPIONATE >A> AB ATRIX EQ 0.05% BASE N76603 001 JAN 23, 2004 JAN NEWA BUPROPION HYDROCHLORIDE TABLET,...
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/dmf/text/4Q2003ACTIVETYPE2TEXT.txt IN INDORE, INDIA" 9242 16-Jul-91 SANDOZ PHARMA LTD "TIZANIDINE HYDROCHLORIDE MFG IN BASLE, SWITZERLAND" 9257 26-Jul-91 MEDICHEM SA "MEXILETINE HYDROCHLORIDE MFG
ANDA Approvals - December 2003 - FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Approvals - December 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 65-161 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP (CHEWABLE) 200 MG/28.5 MG (BASE) AND 400 MG/57 MG (BASE) - RANBAXY LABORATORIES LIMITED 12/3/2003- 2 76-656 FENOLDOPAM MESYLATE INJECTION, USP 10 MG...
Prescription and Over-the-Counter Drug Product List: 10/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA VINTAGE PHARMS 500MG/15ML;7.5MG/15ML N40520 001 OCT 30, 2003 OCT NEWA TABLET; ORAL ANEXSIA >D> AA MALLINCKRODT 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA >A> AA 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA ALBUTEROL SULFATE TABLET...
ANDA Approvals - October 2003 - FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Approvals - October 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 40-416 WARFARIN SODIUM TABLETS, USP 1 MG, 2 MG, 2.5 MG, 3 MG 4 MG, 5 MG, 6 MG, 7.5 MG, AND 10 MG - UPSHER-SMITH LABORATORIES, INC
ANDA Approvals - September 2003 9/12/2003- 18 75-145 SELEGILINE HYDROCHLORIDE CAPSULES 5 MG - AAI PHARMA 9/15/2003- 19 75-763 NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG - IVAX PHARMACEUTICALS, INCHYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG - RANBAXY LABORATORIES LIMITED 9/16/2003- 22 76-037 NEFAZODONE ...
