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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 ...
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Microsoft Word - RPSepicPOM
A Aciclovir 6 Acrivastine 6 Aluminium chloride 6 Aspirin 8, 46 Astemizole 5 Atropine Sulphate 9 Azelastine 8, B Beclomethasone Dipropionate 6, 47 Benzocaine 47 Benzoyl Peroxide 46 Budesonide 8 C Cadexomer- Iodine 8 Camphor 47 Carbenoxolone 6 Cetirizine 6,47 Cimetidine 6 Chloramphenicol 9 Clobetasone 9 Clotrimazole 6,8,46 Co- methiamol 29 D Dequalinium chloride 46 Dextranomer 5...
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
LOUIS, MO" 13842 12-Nov-98 MEDICHEM SA "LORATADINE, MANUFACTURED IN GERONA, SPAIN" 13843 12-Nov-98 CHATTEM CHEMICALS INC "AMMONIUM LACTATE, MANUFACTURED IN CHATTANOOGA, TN" 13844 19-Nov-98 CHEMAGIS LTD "GRANISETRON HYDROCHLORIDE, MANUFACTURED IN BEER SHEVA, ISRAEL" 13845 16-Nov-98 NYCOMED AUSTRIA GMBH "4-METHOXYPHENOL, MANUFACTURED IN LINZ, AUSTRIA" 13846 29-Oct-98 BIDACHEM SPA...
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http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
PHYTONADIONE, USP (VITAMIN K1) MANUFACTURED IN TOKYO, JAPAN AVENTIS PHARMA SA PREDNISOLONE USP MANUFACTURED IN PUTEAUX, FRANCE MAKOR CHEMICALS LTD DACTINOMYCIN CHUGAI PHARMACEUTICAL CO LTD SUCRALFATE CARAFATE TM GANES CHEMICALS INC PROPOXYPHENE NAPSYLATE, BULK FORM-MANUF CARLSTADT, NJ FACILITY LUSOCHIMICA S P A ISOXSUPRINE HYDROCHLORIDE FRANCO INDIAN PHARMACEUTICALS PVT LTD...
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http://www.paddocklabs.com/forms/secundum/volume_9_2.pdf
Rx Ondansetron Hydrochloride 8 mg/ mL in Pluronic/ Lecithin Organogel Ondansetron hydrochloride 800 mg Purified water 20 mL Lecithin/ Isopropyl palmitate 22 mL Pluronic F127 30% gel qs 100 mL Thoroughly pulverize 100 of the 8 mg ondansetron hydrochloride tablets to a very fine powder
Rx Antiemetic Suppositories of the Gralla Type Ingredient #1 #2 #3 #4 #5 #6 #7...
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http://www.paddocklabs.com/forms/secundum/volume_9_2.pdf page 5
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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...
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Prescription and Over-the-Counter Drug Product List: 6/2003
>D> AP + WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUN DISC >A> @ 5,000 UNITS/VIAL N17055 001 JUN DISC >D> AP + 10,000 UNITS/VIAL N17055 002 JUN DISC >A> @ 10,000 UNITS/VIAL N17055 002 JUN DISC GUANABENZ ACETATE TABLET; ORAL GUANABENZ ACETATE >D> AB WATSON LABS EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >A> AB + EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >D> WYTENSIN >D> AB WYETH...
author: AUTHOR
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DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY
Food and Drug Administration • Center for Drug Evaluation and Research Approved Drug Products Search DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION - ACETAMINOPHEN; ASPIRIN; BUTALBITAL CAPSULE OR TABLET; ORAL 160-165MG; 160-165MG; 50MG ACETAMINOPHEN; ASPIRIN; BUTALBITAL CAPSULE OR TABLET; ORAL 325MG; 325MG; 50MG...
author: USERNAME
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CDER Template - Replace Title Here
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - April 2002 - ANDA Number- Drug Name Applicant Approval Date 1 75-521 BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG, AND 15 MG TORPHARM 4/5/02 2 75-863 DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL TABLETS 0.15 MG/0.02 MG AND 0.01 MG RESPECTIVELY (28-DAY CYCLE...
author: USERNAME
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Prescription and Over-the-Counter Drug Product List: 2/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL -A- CODRIX -A- + ANDRX PHARMS 500MG;15MG N40447 001 FEB 26, 2003 FEB NEWA AZATHIOPRINE TABLET; ORAL AZASAN -A- AAIPHARMA LLC 25MG N75252 002 FEB 03, 2003 FEB NEWA -A- AB 50MG N75252 001 JUN 07, 1999 FEB NEWA -A- 75MG N75252 003 FEB 03, 2003 FEB NEWA -A- 100MG N75252 004 FEB 03, 2003...
author: AUTHOR
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FDA Drug Approvals List March 2001
Original Application #: 021082 Approval Date: 01-MAR-01 Trade Name: TAVIST ALLERGY/SINUS/HEADACHE Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET Applicant: NOVARTIS CONSUMER HEALTH INC Active Ingredient(s): ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE OTC/RX Status: OTC Indication(s): For temporary relief of symptoms associated with hay fever...
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FDA Drug Approvals List April 2002
- Drug Approvals for April 2002 Definitions and Notes Original New Drug Applications Original Application #: 021310 Approval Date: 05-APR-02 Trade Name: ALORA Chemical Type: 3 Therapeutic Potential: S Dosage Form: PATCH, CONTROLLED RELEASE Applicant: WATSON LABORATORIES INC Active Ingredient(s): ESTRADIOL OTC/RX Status: RX Indication(s): For the prevention of postmenopausal...
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Prescription and OTC Drug Product List 7/2001
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE -A- AB ABLE 325MG;50MG;40MG N40390 001 JUL 23, 2001 JUL NEWA -A- AB 500MG;50MG;40MG N40394 001 JUL 23, 2001 JUL NEWA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA + WATSON LABS 325MG;7.5MG...
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Prescription and OTC Drug Product List 4/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL ACETAMINOPHEN, BUTALBITAL, CAFFEINE, AND CODEINE PHOSPHATE -A- AB VINTAGE PHARMS 325MG;50MG;40MG;30MG N75929 001 APR 22, 2002 APR NEWA ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE;...
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2003 Export Products List Alphabetical
ORDER # pms- PRODU TS FORMAT OMPARABLE TO LASSIFI ATION ( System): INDI ATIONS PRODU TS AVAILABLE FOR EXPORT Effe tive: July 2003 LISTINGS IN RED ARE C NTR LLED DRUGS Page: 9 pms- holestyramine - pms- o aine Powder 5760633300 N Covan Syrup 100 mL C0- Actifed Syrup Cough Syrup (Codeine Phosphate, Triprolidine Hydrochloride, 5760633301 N Covan Syrup 500 mL Pseudoephedrine ...
author: Lee S. Ehler
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Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices
Conc.( equine) 3.00 mL Dipyridamole 0.14 mg Dobutamine HCI 0.90 mg 5.00 1.10 2.17 3.57 1.80 1.80 1.80 1.80 45.45 5.00 1.25 5.56 11.60 + 0.50 + 35.70 + 71.43 16.70 + 17.20 + 0.70 + 0.70 + 111.00 + 200.00 + 1.00 357.00 0.003 + 0.50 + 166.67 1.00 4.00 0.50 + 1.00 8.77 3.40 + 16.67 1.67 37.70 5.56 40 Dopamine HCI Dopamine HCl in Dextrose Doxapram HCI Injection Doxorubicin HCI for...
author: FDA / CBER
subject: December 1987 Guideline
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Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 36
author: FDA
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Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 29
author: FDA
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Quarterly List of Guidance Documents at the Food and Drug Administration page 12
author: FDA
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Annual Comprehensive List of Guidance Documents at the Food and Drug Administration page 32
author: FDA
subject: 7/21/2000
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http://www.fda.gov/cder/ob/docs/preface/ecbioava.htm
DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION - - ACETAMINOPHEN; ASPIRIN; BUTALBITAL CAPSULE OR TABLET; ORAL 160-165MG; 160-165MG; 50MG ACETAMINOPHEN; ASPIRIN; BUTALBITAL CAPSULE OR TABLET; ORAL 325MG; 325MG; 50MG ACETAMINOPHEN; ASPIRIN; BUTALBITAL; CAFFEINE CAPSULE OR TABLET; ORAL 160-165MG; 160-165MG; 50MG; 40MG...
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Prescription and OTC Drug Product List 5/2001
Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 5: January-May 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE - ADD - ALMOTRIPTAN MALATE CAPSULE; ORAL - ADD - TABLET; ORAL ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE - ADD - AXERT - DLT - + MIKART 150MG;180MG...
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Prescription and OTC Drug Product List 2/2001
PEDIATRIC - ADD - @ 10MG;100MG N74080 001 - ADD - + ASTRAZENECA /1VIL;0.02MG/VIAL;0.001MG/VIAL; - ADD - MAR 25, 1994 - ADD - 5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL; - ADD - @ 25MG;100MG N74080 002 - ADD - 17MG/VIAL;0.2MG/VIAL; - ADD - MAR 25, 1994 - ADD - EQ 1MG BASE/VIAL;1.4MG/VIAL; - ADD - @ 25MG;250MG N74080 003 - ADD - EQ 1.2MG BASE/VIAL;0.7MG/VIAL; - ADD - MAR 25, 1994 - ADD - 7MG...
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PDPL
- ADD - + ADV MAGNETICS EQ 11.2MG IRON/ML N20416 001 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE - ADD - AUG 30, 1996 TABLET; ORAL-21 ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 1/35-21 FLUPHENAZINE DECANOATE - DLT - AB WATSON LABS 0.035MG;1MG N72720 001 - DLT - DEC 30, 1991 INJECTABLE; INJECTION ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 1/50-21 FLUPHENAZINE DECANOATE - DLT - AB WATSON...
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