http://www.fda.gov/cder/orange/appendix_a.txt 2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO,...
Specificity Table TOX.xls Tested (ng/ ml) Roxicet metabolite Morphine metab.( Normorphine) Narcotic analgesic 300,000 OPI 200,000 Roxicet Morphine Narcotic analgesic 100,000 OPI 300 Rynatan Azatadine Antihistaminic 100,000 Salagen Pilocarpine Antiglaucoma 100,000 Salt Sodium chloride Electrolyte replenisher 60,000,000 Samiac Ammonium chloride Expectorant 200,000 Sandimmune Cyclosporin A Immunosuppressant 100...
author: Biosite Incorporated
Specificity Table TOX.xls page 24
author: Biosite Incorporated
Drug Approvals - B - ANDA 76-476 2/11/04 2/12/04 - - Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Andrx Pharmaceuticals ANDA 76-267 2/11/04 2/12/04 - - Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Tentatively Approved Andrx Pharmaceuticals ANDA 76-267 2/26/03 - - - Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Teva Pharmaceuticals ANDA 76-211 2/11/04 2...
NDA Approvals for Calendar Year 2003 NDA APPROVALS FOR CALENDAR YEAR 2003 Updated through December 31, 2003 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21434 Xanax XR Alprazolam Pharmacia and Upjohn FR 3 S 17-Jan-03 21305 Sodium Iodide I-131 Sodium Iodide I-131 DraxImage 3,5 S 24-Jan-03 20414 Pyridostigmine Bromide Pyridostigmine Bromide US Army 3 P 05-Feb-03...
author: Susan Daugherty
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt METFORMIN HYDROCHLORIDE (LA 6023) 5954 09-Jul-85 BOEHRINGER INGELHEIM CHEMICALS INC METHOCARBAMOL 5966 08-Aug-85 ESTEVE QUIMICA SA ALPHA METHYLDOPA 5967 13-Aug-85 SARTORIUS FILTERS INC "FILTER MEMBRANE MATERIALS MANUFACTURED AT GOTTINGEN, GERMANY AND YAUCO PUERTO RICO" 5972 13-Aug-85 BOEHRINGER INGELHEIM CHEMICALS INC GUAIFENESIN 5974 20-Aug-85 NAPP CHEMICALS INC SULFANILAMIDE...
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
http://www.paddocklabs.com/forms/secundum/volume_9_2.pdf Rx Fentanyl 35 µg/ mL, Bupivacaine 1 mg/ mL and Clonidine 9 µg/ mL Intrathecal Solution Fentanyl 3.5 mg* Bupivacaine hydrochloride 100 mg Clonidine 900 µg 0.9% Sodium chloride injection qs 100 mL *commercial preservative- free injectable Fentanyl labeled as Fentanyl base/ mLHydrochloride Epidural Injection...
http://www.paddocklabs.com/forms/secundum/volume_9_2.pdf page 4
Prescription and Over-the-Counter Drug Product List: 5/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
FDA Drug Approvals List January 2002 - Drug Approvals for January 2002 Definitions and Notes Original New Drug Applications Efficacy Supplemental New Drug Applications Application #: 020837 Efficacy Supplement #: 006 Type: SE5 to Original New Drug Application Approval Date: 30-JAN-02 Trade Name: XOPENEX Dosage Form: SOLUTION Applicant: SEPRACOR, INC Active Ingredient(s): LEVALBUTEROL HYDROCHLORIDE OTC/RX Status:...
Prescription and OTC Drug Product List 6/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA PEACHTREE 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN -A- AA UCB 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE TABLET; ORAL DARVOCET -A- @ AAIPHARMA LLC 325MG;32.5MG N16844 001 JUN CAHN ...
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...
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 at 56- 57oC) 3.00 mL Antirabies Serum 3.00 mL Antitoxin (Gas Gangrene) 3.00 mL Antivenom 3.00 mL Apommorphine HCl Tablets for Injection 0.09 mg Arginine HCl Injection 500.00 mg Ascorbic Acid 4.20 mg Asparaginase for Injection 1000.00 Iu Atracurium Besylate 0.50 mg Atropine Sulfate 0.09 mg Aurothioglucose Suspension 0.70 mg Azathioprine Sodium for Injection 5.00 mg Azlocillin 75.00 mg...
author: FDA / CBER
subject: December 1987 Guideline
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 page 3
author: FDA / CBER
subject: December 1987 Guideline
http://www.fda.gov/cder/da/ddpa93.wpd DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER APPROVAL DATE (CLASSIFICATION)TRADE NAME (DOSAGE FORM)APPLICANTACTIVE INGREDIENT(S) STRENGTH(S) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 18 936 PROZAC LILLY FLUOXETINE HYDROCHLORIDE 12-23-92 (CAPSULE) INDIANAPOLIS, IN EQ 10MG BASE (SUPPL) 46285 (NEW STRENGTH) 19 627...
