IROA - Scientific Study Reference Search Pellets 2-Acetamidofluorene (2-AAF) 2-Acetylaminofluorene (AAF) 2-OHE1 3,3',5-Triiodo-L-Thyronine (T3) 4-Hydroxyandrostene-3,17-dione (4-OHA) 4-Hydroxyandrostenedione 5a-Androstan-3a + 17ss-diol 5a-Dihydrotestosterone (5a-DHT) 5a-Dihydrotestosterone (5a-DHT) 5a-Reductase Inhibitor (4MA) 5-Bromo-2'-Deoxyurdine (BrDU) 5a-Dihydrotestosterone (5a-DHT) 6-n-Propyl-2-Thiouracil (PTU...
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Orange Book Preface 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 PREFACE The publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List), identifies drug products approved on the...
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,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt BISACODYL 2277 17-May-74 ROCHE DIAGNOSTICS GMBH DIGOXIN PRODUCTS 2303 11-Jul-74 SOLMAG S.P.A DICYCLOMINE HYDROCHLORIDE 2314 08-Aug-74 CHATTEM CHEMICALS INC AMPHETAMINE BULK AND DEXTRO DESOXYEPHEDRINE 2318 23-Aug-74 TAKEDA CHEMICAL INDUSTRIES LTD FOLIC ACID 2364 26-Nov-74 AVENTIS PHARMA SA NORGESTERAL ACETATE OXIME 2368 10-Dec-74 INDUSTRIA CHIMICA MILANESE SPA "PROCHLORPERAZINE...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls IN BUDAPEST, HUNGARY PLANTEX LTD CHEM AND PHARM WORKS IMIPRAMINE HYDROCHLORIDE LUNDBECK PHARMACEUTICALS ITALY SPA IMIPRAMINE HYDROCHLORIDE AVENTIS PHARMA SA PROMETHAZINE HCL GRUPPO LEPETIT SPA D-PROPOXYPHENE HYDROCHLORIDE BULK SCHERING AG ETHINYL ESTRADIOL ROCHE COLORADO CORPORATION
Prescription and Over-the-Counter Drug Product List: 11/2003 ACTHAR GEL >D> BC + QUESTCOR PHARMS 80 UNITS/ML N08372 008 NOV CTEC >A> + 80 UNITS/ML N08372 008 NOV CTEC CYTARABINE INJECTABLE; INJECTION >D> CYTARABINE >D> AP + GENSIA SICOR PHARMS 100MG/VIAL N16793 001 NOV DISC >D> AP + 500MG/VIAL N16793 002 NOV DISC >D> AP + 1GM/VIAL N16793 003 DEC 21, 1987 NOV DISC >D> AP + 2GM/VIAL N16793 004 DEC 21, 1987 NOV DISC >A> @ SICOR PHARMS 100MG/VIAL...
Prescription and Over-the-Counter Drug Product List: 8/2003 4 >D> AA + ORTHO MCNEIL PHARM 300MG;60MG N85055 004 AUG DISC >A> @ 300MG;60MG N85055 004 AUG DISC ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA + MALLINCKRODT 500MG/15ML;10MG/15ML N40508 001 AUG 29, 2003 AUG NEWA >D> MIKART 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG CTEC >A> AA 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG...
author: AUTHOR
Approved Drug Products Preface, 21st edition Food and Drug Administration • Center for Drug Evaluation and Research Approved Drug Products Search Food and Drug Administration Center for Drug Evaluation and Research Approved Drug Products with Therapeutic Equivalence Evaluations PREFACE TO TWENTY SECOND EDITION - The publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List), identifies drug...
author: USERNAME
1997 New Drug Application (NDA) 020051/S008 1/10/1997 3/20/1998 Humalog/Insulin Lispro (rDNA Origin) Injection [2 MB] Eli Lilly and Company 020563/S003 07/16/1997 5/11/1998 Humatrope/Somatropin (rDNA orgin) [13.3 MB] Eli Lilly and Company 019640/S018 019640/S019 3/11/1997 11/7/1997 Hydralazine - Company: Luitpold Pharmaceutical Application No.: 040136 06/30/1997 8/1/2003 Imitrex/Sumatriptan Part 1 [8.4 MB]...
1997 Abbreviated New Drug Applications (Generic Drugs) 074946 11/19/1997 3/30/1998 Adriamycin PFS (Doxorubicin Hydrochloride) Injection ,- Adria Laboratories 63165/S3, S5, S6 7/9/1993 8/8/2002 Albuterol Inhalation Aerolsol, 90 mcg/ActuationHydrochloride [2 MB] Taro Pharmaceuticals 074694 12/13/1996 12/3/1997 Clomipramine Hydrochloride Capsules, 25, 50, & 75 mg
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...
FDA Drug Approvals List February 2000 - Drug Approvals for February 2000 Definitions and Notes Original New Drug Applications Original Application #: 021015 Approval Date: 28-FEB-00 Trade Name: ANDROGEL Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: UNIMED PHARMACEUTICALS INC Active Ingredient(s): TESTOSTERONE OTC/RX Status: RX Indication(s): For replacement therapy in males for conditions...
SSCI Inc.: X-ray Powder Diffraction, Raman and Infrared Spectroscopy, Differential Scanning Calorimetry, and Thermogravimetric Phone: 800 375-2179 / 765 463-0112 Fax: 765 497-2649 / 765 463-4722 E-mail: info@ssci-inc.com SSCI Inc., 3065 Kent Avenue, West Lafayette, IN 47906 - 1076 USA Acetaminophen Acetazolamide Acetohexamide Acetylcysteine Acyclovir Adenine L-Alanine Albuterol Albuterol Sulfate Allopurinol Alprazolam Amantadine HCl Amiloride HCl Aminobenzoic Acid Aminoglutethimide Aminosalicylic Acid...
author: SSCI Webmaster
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
http://www.paddocklabs.com/forms/secundum/volume_6_2.pdf Drug Concentration( mg/ mL) Alprazolam 1 Bethanechol 5 Chloroquine Phosphate 15 Cisapride 1 Enalapril Maleate 1 Hydralazine Hydrochloride 4 Pyrazinamide 10 Quinidine Sulfate 10 Rifampin 25 Tetracycline Hydrochloride 25 Capsules were emptied into a mortar and the powder broken up with a pestleHydralazine Hydrochloride Hydralazine ...
http://www.paddocklabs.com/forms/secundum/volume_6_2.pdf page 5
http://www.paddocklabs.com/forms/secundum/volume_6_2.pdf page 3
http://www.paddocklabs.com/forms/secundum/volume_6_2.pdf page 1
http://www.paddocklabs.com/forms/secundum/volume_8_4.pdf Topical Gel (Pluronic- Lecithin Organogel) Examples: Rx Amitriptyline Hydrochloride 2% in PLO Amitriptyline hydrochloride 2 g Ethanol, 95% 5 mL Lecithin/ Isopropyl palmitate solution 22 mL Pluronic F- 127 20% gel qs 100 mL Mix the amitriptyline hydrochloride with the alcohol to form a smooth pasteHydrochloride in PLO Capsaicin 50 mg Ketamine...
http://www.fda.gov/cder/foi/appletter/2001/40388ltr.pdf ANDA 40- 388 March 13, 2001 American Pharmaceutical Partners, IncHydralazine Hydrochloride Injection...
http://www.fda.gov/cder/foi/appletter/2001/40388ltr.pdf page 1
Prescription and OTC Drug Product List 11/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 11: November 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE CLOBETASOL PROPIONATE TABLET; ORAL OINTMENT; TOPICAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN EMBELINE - ADD - ENDO PHARMS 400MG;5MG N40288 001 - ADD - AB...
Prescription and OTC Drug Product List 8/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 8: August 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL - ADD - BUTALBITAL, ACETAMINOPHEN AND CAFFEINE MODURETIC 5-50 - ADD - AB...
