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NUMERICAL INDEX
NUMERICAL INDEX 000455 see Thyroid Panel 000620 see Thyroid Panel With TSH 000679 see Hemoglobinopathy Profile 000703 see Renin Activity and Aldosterone 000810 see Vitamin B12 and Folates 001016 see Calcium, Serum 001024 see Phosphorus, Serum 001032 see Glucose, Serum 001040 see Urea Nitrogen, Serum 001057 see Uric Acid, Serum 001065 see Cholesterol, Total 001073 see Protein, Total,...
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Tobramycin-BSA - from Fitzgerald Industries International, Inc. - Catalog # 80-IT25
Contact Info Request a Catalog Join Our Mailing List International Distributors Telephone Orders Fax and E-mail Mail Orders Payment Terms Other Ordering Info FII News Technical Updates Special Offers Tradeshows and Meetings Tobramycin-BSA, influenza a, influenza b, monoclonal, monoclonals, monoclonal antibody, monoclonal antibodies, strep a, streptococci group a, hcg beta,...
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Esoterix, Inc. -- Test Menu
Screen Profile (Panel includes immunity screen for Rubeola, Mumps, Rubella, Varicella Zoster) 500375 Macroprolactin 500652 Magnesium 501261 Magnesium, Urine 608010 Malaise Profile (Panel includes IgG antibodies for CMV, Epstein Barr VCA, HSV 1 & 2, HHV-6, Rubella, Toxoplasma, Varicella Zoster) 600159 Malaria Smears 135160 Malathion (Monocarboxylic acid; Dicarboxylic acid), Urine...
author: Esoterix, Inc.
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CDER Guidance Documents
(Issued 8/2000, Posted 8/8/2000) Joint Safety/Efficacy (Multidisciplinary) (Draft) Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001) [ PDF ] M4 Common Technical Document--Quality: Questions and Answers/Location Issues [ HTML ] or [ PDF ] or [ ] (Issued 9/12/2002, Posted 12/30/2002) Quality Q1E Evaluation of...
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Drug Approvals - N
Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Nabumetone Tablets, 500 mg, Rx- Second (Tentative Approval) Copley Pharmaceutical, Inc
NDA 20-388/S8 6/8/00 6/19/02 6/19/02 6/19/02 Nebcin (tobramycin sulfate injection, USP)-Vials and Hyporets, Rx Eli Lilly and Company NDA 50-477/S-024 & 50-519/S-024 4/2/03 4/18/03 Nefazodone...
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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,...
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1998 Warning Letters and Untitled Letters to Pharmaceutical Companies
DDMAC 4/27 5/7 MUSE (alprostadil) urethral suppository Vivus DDMAC 4/1 4/9 Nicotrol Inhaler (nicotine) inhalation system McNeil Consumer Products DDMAC 4/6 4/16 Norvasc (amlodipine besylate) Tablets Pfizer Pharmaceuticals Group DDMAC 4/24 4/28 Oxistat (Oxiconazole Nitrate Cream) GlaxoWellcome DDMAC 5/19 5/29 Propecia (finasteride) Tablets Merck DDMAC 4/1 4/9 Serevent Diskus ...
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
"LINCOMYCIN HYDROCHLORIDE MANUFACTURED IN SUZHOU, CHINA" 13758 01-Sep-98 CIPAN SARL MINOCYCLINE HYDROCHLORIDE 13759 01-Sep-98 RANBAXY LAB LTD CEPHALEXIN 13760 01-Sep-98 "CHONGQING DAXIN PHARMACEUTICAL CO., LTD." "AMIKACIN BASE AS MANUFACTURED IN CHONGQING, CHINA" 13762 01-Sep-98 ACS DOBFAR AMIKACIN SULFATE 13763 01-Sep-98 ACS DOBFAR AMIKACIN SULFATE 13764 01-Sep-98...
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http://www.fda.gov/cder/dmf/text/4Q2003NEWTEXT.txt
CHINA." 16810 II 20-Aug-2003 ALPHARMA APS "TOBRAMYCIN SULFATE, USP STERILE AS MANUFACTUREED IN COPENHAGE, DENMARK" 16812 II 28-Aug-2003 "CAMBRIDGE MAJOR LABORATORIES, INC." "FP-043 AS MANUFACTURED IN GERMANTOWN, WI." 16813 II 3-Sep-2003 UCB BIOPRODUCTS "DESMOPRESSIN (ACETATE) AS MANUFACTURED IN BRAINE-L'ALLEUD, BELGIUM." 16818 II 26-Aug-2003 KUMAR ORGANIC PRODUCTS LIMITED...
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http://www.fda.gov/cder/dmf/xls/4Q2003NEWEXCEL.xls
Arthur Shaw CDER User $ ($) $ ($) $ ($) $ ($) $ $ () $ - () - $ $ () $ - () - -- -- $ ($) $ ($) $ ($) $ ($) / / // -- - - : : :: : () () () () () - $ $ () $ - () - $ $ () $ - : :: : 4Q2003NEWEXCEL DMF # Type SUBMIT DATE HOLDER SUBJECT IV COGNIS DEUTSCHLAND GMBH CO KG MYRITOL(R) 318 PH AS MANUFACTURED IN DUESSELDORF, GERMANY
II ALPHARMA APS TOBRAMYCIN SULFATE, USP...
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Genzyme Tissue Repair
1 65009 Revision C 10/ 2002 Epicel (cultured epidermal autografts) Humanitarian Device: Authorized by Federal law for use in patients who have deep dermal or full thickness burns comprising a total body surface area of greater than or equal to 30% and in congenital nevus patients
Agent Maximum Dose* Agent Maximum Dose* Amphotericin B 24 µg/ ml Polymyxin B Sulfate 1000 U...
author: MIS
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Genzyme Tissue Repair page 5
author: MIS
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Prescription and Over-the-Counter Drug Product List: 8/2003
4MG/HR N74607 001 AUG 30, 1996 AUG CRLD >A> AB2 + 0.4MG/HR N74607 001 AUG 30, 1996 AUG CRLD >D> AB2 0.6MG/HR N74559 001 AUG 30, 1996 AUG CRLD >A> AB2 + 0.6MG/HR N74559 001 AUG 30, 1996 AUG CRLD >D> TRANSDERM-NITRO >D> AB2 + NOVARTIS 0.1MG/HR N20144 001 FEB 27, 1996 AUG DISC >A> @ 0.1MG/HR N20144 001 FEB 27, 1996 AUG DISC >D> AB2 + 0.2MG/HR N20144 002 FEB 27, 1996 AUG DISC >A> @ 0.2MG...
author: AUTHOR
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ANDA Approvals February 2002
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - February 2002 - ANDA Number Drug Name Applicant Approval Date 1 75-810 FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) BARR LABORATORIES, INC
PERRIGO COMPANY 2/7/02 9 76-193 PROPAFENONE HYDROCHLORIDE TABLETS 150 MG, 225 MG, AND 300 MG KV PHARMACEUTICAL COMPANY 2/7/02 10 40...
author: USERNAME
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RLD LABELING APPROVED IN SEPTEMBER 1998
Firm Date PREMARIN Conjugated Estrogen Tablets 4-782 S-093 Wyeth Ayerst 08-Sep-1998 TOBI Tobramycin Sol 50-753 S-001 Pathogenesis Corp 11-Sep-1998 VIRAMUNE Nevirapine Tablets 20-636 S-009 Boehringer Ingelheim 11-Sep-1998 ZYFLO Zileuton Tablets 20-471 S-007 Abbott Lab 11-Sep-1998 VEXOL Rimexolone Suspension 20-474 S-007 Alcon 11-Sep-1998 INTEGRILIN Eptifibatide Injection 20-718...
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FDA Drug Approvals List August 2001
Active Ingredient(s): PREDNISONE OTC/RX Status: RX Original Abbreviated Application # 075733 Approval Date: 22-AUG-01 Trade Name: CLOBETASOL PROPIONATE Dosage Form: EMULSION, CREAM Applicant: STIEFEL LABORATORIES INC Active Ingredient(s): CLOBETASOL PROPIONATE OTC/RX Status: RX Original Abbreviated Application # 074911 Approval Date: 22-AUG-01 Trade Name: PHRENILIN Dosage Form:...
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FDA Drug Approvals List March 2002
- Drug Approvals for March 2002 Definitions and Notes Original New Drug Applications Original Application #: 020855 Approval Date: 21-MAR-02 Trade Name: MESNA Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: ASTA MEDICA AG Active Ingredient(s): MESNA OTC/RX Status: RX Indication(s): For the use as a prophylactic agent in reducing the incidence of ifosfamide...
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Prescription and OTC Drug Product List 12/2001
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE CAPSULE; ORAL SYNALGOS-DC-A -A- @ WOMEN FIRST HLTHCARE 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN -D- @ WYETH AYERST 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL ANEXSIA 5/325 -D- AA MALLINCKRODT 325MG;5MG N40409...
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Prescription and OTC Drug Product List 9/2001
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- ENDO PHARMS 400MG;5MG N40288 001 NOV 27, 1998 SEP CTEC -D- 400MG;7.5MG N40288 002 NOV 27, 1998 SEP CTEC -D- 400MG;10MG N40288 003 NOV 27, 1998 SEP CTEC -A- + 400MG;5MG N40288 001 NOV 27, 1998 SEP CTEC -A- + 400MG;10MG N40288 003 NOV 27, 1998 SEP CTEC -A- + 400MG;7.5MG...
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Prescription and OTC Drug Product List 8/2001
ACTHAR GEL -D- BC + AVENTIS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -D- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN -A- BC + QUESTCOR PHARMS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -A- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN DELAVIRDINE MESYLATE TABLET; ORAL RESCRIPTOR -D- + AGOURON 100MG N20705 001 APR 04, 1997 AUG CRLD -A- 100MG N20705 001 APR 04, 1997 AUG...
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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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Prescription and OTC Drug Product List 2/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION; ORAL AUGMENTIN '400' -D- + GLAXOSMITHKLINE 400MG/5ML;EQ 57MG BASE/5ML N50725 002 MAY 31, 1996 FEB CRLD -A- 400MG/5ML;EQ 57MG BASE/5ML N50725 002 MAY 31, 1996 FEB CRLD AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE...
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Prescription and OTC Drug Product List 1/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA KV PHARM 500MG/15ML;7.5MG/15ML N40366 001 JAN 23, 2002 JAN NEWA AMPHOTERICIN B INJECTABLE, LI COMPLEX; INJECTION ABELCET -A- + ELAN PHARMS 5MG/ML N50724 001 NOV 20, 1995 JAN CAHN -D- + LIPOSOME 5MG/ML N50724 001 NOV 20, 1995 JAN...
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C:\Data\NDA\Capastat\03JuneApLetterS044.doc.doc
NDA 50- 095/ S- 044 Page 3 2.01 PA 7954- A UCP CAPASTAT ® SULFATE CAPREOMYCIN FOR INJECTION, USP For Intramuscular and Intravenous Infusion Only Not for Pediatric Use WARNINGS The use of Capastat ® Sulfate (Capreomycin for Injection, USP) in patients with renal insufficiency or preexisting auditory impairment must be undertaken with great caution, and the risk...
author: Christine Lincoln
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C:\Data\NDA\Capastat\03JuneApLetterS044.doc.doc page 1
author: Christine Lincoln
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