http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN PHENAPHEN-650 W/ CODEINE, ACETAMINOPHEN PHENAZINE, PHENDIMETRAZINE TARTRATE PHENAZINE-35, PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDE PHENERGAN PLAIN, PROMETHAZINE HYDROCHLORIDE PHENERGAN VC W/ CODEINE, CODEINE PHOSPHATE PHENERGAN VC, PHENYLEPHRINE HYDROCHLORIDE PHENERGAN W/ CODEINE, CODEINE...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 4Q2003 TYPE2ACTIVETEXT DMF # SUBMIT DATE HOLDER SUBJECT 131 01-Jan-40 CENTRAL SOYA SOYBEAN STEROL PRODUCTS 183 29-Feb-52 INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 191 24-Jan-56 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE) 240 11-Jan-57 PHARMACIA & UPJOHN 19-NOR-ETHINYLTESTOSTERONE 281 21-Nov-57 UNIMED PHARMACEUTICALS INC 2 HYDROXY...
21-169_Reminyl.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Reminyl (Galantamine Hydrobromide) Tablets Company:--Janssen Research Foundation Application No.:--21-169 Approval Date:-2/28/2001 - Approval Letter(s) - Printed Labeling - Medical Review(s)- Part 1 - Part 4 - Part 7 - Part 2 - Part 5 - Part 8 - Part 3 - Part 6 - Part 9 -...
author: Paul Stauffer
21-224_REMINYL Oral Solution Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Reminyl (Galantamine Hydrobromide) Oral Solution Company:--Janssen Research Foundation Application No.:--21-224 Approval Date:-6/22/2001 - Approval Letter(s) - Printed Labeling - Medical Review(s) - Chemistry Review(s) - Clinical Pharmacology Biopharmaceutics Review(s) -...
author: Paul Stauffer
Prescription and Over-the-Counter Drug Product List: 4/2003 45 -D- XCEL PHARMS 1MG/ML N05929 001 APR CFTG -A- AP + 1MG/ML N05929 001 APR CFTG -A- DIHYDROEROGTAMINE MESYLATE -A- AP PADDOCK 1MG/ML N40475 001 APR 28, 2003 APR NEWA DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL -A- TAZTIA XT -A- AB4 ANDRX PHARMS 120MG N75401 001 APR 10, 2003 APR NEWA -A- AB4 180MG N75401 002 APR 10, 2003 APR NEWA -A- AB4 240MG N75401 003 APR 10, 2003 APR...
author: AUTHOR
NDA Approvals for Calendar Year 2001 Braun 5 S 21-Feb-01 21-235 Prozac Weekly Fluoxetine Hydrochloride Eli Lilly 3 S 26-Feb-01 21-169 Reminyl Galantamine Hydrobromide Janssen Research 1 S 28-Feb-01 21-082 Tavist Allergy/Sinus/Headache Acetaminophen/Clemastine Fumarate/Pseudoephedrine Hydrochloride Novartis 4 S 01-Mar-01 21-257 Travatan Travoprost Alcon 1 P 16-Mar-01 21-262 Alphagan P Brimonidine Tartrate...
author: Brenda Harmon
FDA Drug Approvals List June 2001 Catarrhalis (including B-lactamase-producing strains) Original Application #: 021224 Approval Date: 22-JUN-01 Trade Name: REMINYL Chemical Type: 3 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: JANSSEN RESEARCH FDN Active Ingredient(s): GALANTAMINE HYDROBROMIDE OTC/RX Status: RX Indication(s): For the treatment of mild to moderate dementia of the Alzheimer's...
FDA Drug Approvals List February 2001 - Drug Approvals for February 2001 Definitions and Notes Original New Drug Applications Original Application #: 021169 Approval Date: 28-FEB-01 Trade Name: REMINYL Chemical Type: 1 Therapeutic Potential: S Dosage Form: TABLET Applicant: JANSSEN RESEARCH FDN Active Ingredient(s): GALANTAMINE HYDROBROMIDE OTC/RX Status: RX Indication(s): For the treatment of mild to...
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...
Forum - Read Topic Cyanotis arachnoidea 90% UV-VIS 0„70‡0-ecdysone Beta-ecdysone Dahurian Rhodoendron Leaf Dahurian Rhodoendron 70% UV-VIS Proanthocyandidins Dandelion Root Extract Taraxacum officinale 3% UV-VIS Flavonoids Dan-shen Extract Salvia Miltiorrhiza 95% HPLC Total Tanshinones Dan-shen Extract Salvia Miltiorrhiza 95% HPLC Tanshinone 0„4¡§¡aA Dan...
114_P450 Substrates & Products PRODUCT CATEGORIES Oxidative Stress Xenobiotic Metabolism Eicosanoid Metabolism Vascular Biology Signal Transduction Cancer Biology PRODUCTS BY APPLICATION Assay Kits Antibodies Enzymes and --Recombinant Proteins Substrates and --Inhibitors cDNA Probes, Primers --and Constructs CYP Substrates & Products The following compounds are useful as standards in studies which utilize...
Product Inquiry -- Search - Biochemicals Amino Acids Antibiotics Biological Buffers Detergents Enzyme Substrates Inorganic Reagents Molecular Biology Organic Reagents Stains & Dyes Vitamins ---- You are here: Home » Biochemicals » Enzyme Substrates » Dextromethorphan...Hydrobromide, substrate...
Dextromethorphan Hydrobromide, substrate for Cytochrome P450 2D6 -- Search - Biochemicals Amino Acids Antibiotics Biological Buffers Detergents Enzyme Substrates Inorganic Reagents Molecular Biology Organic Reagents Stains & Dyes Vitamins ---- You are here: Home » Biochemicals » Enzyme Substrates » Dextromethorphan Hydrobromide,... Hydrobromide, substrate for Cytochrome P450 2D6 -For pricing...
Orange Book Appendix: Uniform Terms FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH APPROVED DRUG PRODUCTS with Therapeutic Equivalence Evaluations 24th Edition Appendix: Uniform Terms Dosage Forms AEROSOL AEROSOL, METERED CAPSULE CAPSULE, COATED PELLETS CAPSULE, DELAYED REL PELLETS CAPSULE, EXTENDED...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls Arthur Shaw CDER User $ ($) $ ($) $ ($) $ ($) $ $ () $ - () - $ $ () $ - () - -- -- $ ($) $ ($) $ ($) $ ($) / / // -- - - : : :: : () () () () () - $ $ () $ - () - $ $ () $ - : :: : 4Q2003 TYPE2ACTIVEEXCEL DMF # SUBMIT DATE HOLDER SUBJECT CENTRAL SOYA SOYBEAN STEROL PRODUCTS INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE ...
http://www.fda.gov/cder/dmf/text/4Q2003NEWTEXT.txt 16945 III 6-Nov-2003 SILGAN PLASTIC CORP "INJECTION MOLDED PLASTIC CLOSURE - LINED AND UNLINED / LINERLESS AS MANUFACTURED IN PENN YAN, NY; PLAINFIELD, IN; QUEBEC AND ONTARIO, CANADA" 16946 II 7-Nov-2003 BASF CORP "POLYETHYLENE GLYCOLS AS MANUFACTURED IN WASHINGTON, NJ." 16947 II 7-Nov-2003 TEVA GROUP "DESMOPRESSIN AS MANUFACTURED IN BE'ER SHEVA AND NETANYA, ISRAEL." 16948 II 7-Nov...
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
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004 FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -OGD Suitability Tracking Report (Sorted by Petition Number) as of 1/5/2004 Drug/Strength Petition No/Firm Dosage Form Status Status Date ACETAMINOPHEN 300 MG HYDROCODONE BITARTRATE 5 MG, 7.5 MG, 10 MG - 03P-0436/CP1 ANABOLIC LABORATORIES - - - 9/22/2003- TRIPELENNAMINE HYDROCHLORIDE 25 MG/5...
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004 - TABLETS FOR ORAL SUSPENSION Approved 6/13/2000- CEFAZOLIN SODIUM, STERILE 100 G & 300 G - 99P-4870/CP1 QUINN CONSULTING SERVICES - FOR INJECTION Approved 4/12/2002- CEFOXITIN 100 GRAM, 300 GRAM - 03P-0227/CP1 SAMSON MEDICAL TECHNOLOGIES - INJECTION Approved 10/1/2003- CEFPODOXIME PROXETIL 50 mg, 100 mg - 02P-0444/CP1 THE WEINBERG GROUP - TABLETS FOR ORAL SUSPENSION Pending -...
http://www.paddocklabs.com/forms/secundum/volume_9_2.pdf Secundum Artem VOLUME 9 NUMBER 2 Current & Practical Compounding Information for the Pharmacist
http://www.paddocklabs.com/forms/secundum/volume_9_2.pdf page 5
Prescription and Over-the-Counter Drug Product List: 6/2003 >D> AT ALLERGAN 1% N61187 001 JUN DISC >A> @ 1% N61187 001 JUN DISC >D> SOLUTION/DROPS; OPHTHALMIC >D> CHLOROPTIC >D> + ALLERGAN 0.5% N50091 001 JUN DISC >A> @ 0.5% N50091 001 JUN DISC >D> CHLOROQUINE HYDROCHLORIDE >D> INJECTABLE; INJECTION >D> ARALEN HCL >D> + SANOFI SYNTHELABO EQ 40MG BASE/ML N06002 002 JUN DISC >A> @ EQ 40MG BASE/ML N06002 002 JUN DISC CHLORPROMAZINE HYDROCHLORIDE...
author: AUTHOR
Appendix: Uniform Terms Food and Drug Administration • Center for Drug Evaluation and Research Approved Drug Products Search APPENDIX UNIFORM TERMS [ Dosage Forms ] [ Routes of Administration ] [ Abbreviations ] - DOSAGE FORMS AEROSOL AEROSOL, METERED BAR, CHEWABLE CAPSULE CAPSULE, COATED PELLETS CAPSULE, DELAYED REL PELLETS CAPSULE, EXTENDED RELEASE CONCENTRATE CREAM CREAM, AUGMENTED CREAM,...
author: USERNAME
NMEs Approved in CY 2002 NMEs Approved in Calendar Year 2002 - NDA Number Generic Name Trade Name Dosage Form Applicant *Classification Approval Date 21-232 Nitisinone Orfadin Capsule Swedish Orphan -- 1PV 01-18-2002 21-286 Olmesartan Medoxomil Benicar Tablet Sankyo- 1S 04-25-2002 21-344 Fulvestrant Faslodex Injection AstraZeneca 1S 04-25-2002 21-272 Treprostinil Sodium Remodulin Injection United...
author: Susan Daugherty
Prescription and Over-the-Counter Drug Product List: 3/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG;30MG N40441 001...
author: AUTHOR
