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 SILVER SULFADIAZINE 4298 22-Oct-81 SCHERING PLOUGH AVONDALE CO DEXCHLORPHENIRAMINE MALEATE 4305 22-Oct-81 LOFTUS BRYAN CHEMICALS LTD CHLORPHENIRAMINE MALEATE 4312 21-Oct-81 SCHERING PLOUGH AVONDALE CO DEXBROMPHENIRAMINE MALEATE 4313 03-Nov-81 AVECIA INC "SDM 27 (10% NITROGLYCERIN IN PROPYLENE GLYCOL) MANUFACTURED IN TAMAQUA, PA." 4317 15-Oct-81 SCHERING...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls SILVER SULFADIAZINE SCHERING PLOUGH AVONDALE CO DEXCHLORPHENIRAMINE MALEATE LOFTUS BRYAN CHEMICALS LTD CHLORPHENIRAMINE MALEATE SCHERING PLOUGH AVONDALE CO DEXBROMPHENIRAMINE MALEATE AVECIA INC SDM 27 (10% NITROGLYCERIN IN PROPYLENE GLYCOL) MANUFACTURED IN TAMAQUA, PA
Prescription and Over-the-Counter Drug Product List: 11/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST >A> ABARELIX >A> INJECTABLE; INTRAMUSCULAR >A> PLENAXIS >A> + PRAECIS 100MG/VIAL N21320 001 NOV 25, 2003 NOV NEWA ALBUTEROL SULFATE SOLUTION; INHALATION ALBUTEROL SULFATE >A> AN BREATH LTD EQ 0.083% BASE N76370 001 NOV 24, 2003 NOV NEWA BACLOFEN TABLET, ORALLY DISINTEGRATING; ORAL KEMSTRO >D> SCHWARZ PHARMA 10MG N21589 001 OCT 30...
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
1997 Abbreviated New Drug Applications (Generic Drugs) Generic Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
FDA Drug Approvals List February 2001 Approvable Original New Drug Applications - Original Abbreviated New Drug Applications Original Abbreviated Application # 075402 Approval Date: 28-FEB-01 Trade Name: METAPROTERENOL SULFATE Dosage Form: SOLUTION Applicant: NOVEX PHARMA Active Ingredient(s): METAPROTERENOL SULFATE OTC/RX Status: RX Original Abbreviated Application # 075403 Approval Date: 28-FEB-01 Trade Name:...
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...
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...
Prescription and OTC Drug Product List 10/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 325MG;7.5MG N40464 001 OCT 23, 2002 OCT NEWA -A- AA 325MG;10MG N40464 002 OCT 23, 2002 OCT NEWA -A- AA 650MG;10MG N40476 001 OCT 23, 2002 OCT NEWA -A- AA 750MG;7.5MG N40469 001 OCT 25, 2002 OCT NEWA -A- AA MALLINCKRODT 750MG...
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
DDPA October 1995 19-672 EFIDAC 24 ALZA BROMPHENIRAMINE MALEATE 20-OCT-95 PSEUDOEPHEDRINE/ PALO ALTO, CA 16MG BROMPHENIRAMINE 94303 PSEUDOEPHEDRINE (TABLET, HYDROCHLORIDE EXTENDED RELEASE) 240MG (ANTIHISTAMINE/DECONGESTANT) (OTC) 20-520 ZANTAC 75 GLAXO WELLCOME RANITIDINE HYDROCHLORIDE 23-OCT-95 (TABLET) RES TRIANGLE PK, NC EQ 75MG BASE 27709 (HISTAMINE H-2 RECEPTOR ANTAGONIST) (OTC)...
DDPA April 1996 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 20-262 TAXOL BRISTOL MYERS SQUIBB PACLITAXEL 01-APR-96 (INJECTABLE) WALLINGFORD, CT 6MG/ML 06492 (LABELING REVISION -- BOXED WARNING; DESCRIPTION; WARNINGS; PRECAUTIONS; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION; HOW SUPPLIED) 18-602 CARDIZEM HOECHST MARION RSSL DILTIAZEM HYDROCHLORIDE 02-APR-96 (TABLET) KANSAS CITY, MO 30MG 64134 60MG...
DDPA March 1996 Drug and Device Product Approvals for March 1996 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-659 NORVIR ABBOTT RITONAVIR 01-MAR-96 (SOLUTION) ABBOTT PARK, IL 80MG/ML (1 P, H*) 60064 (ANTIVIRAL) [TREATMENT OF HIV INFECTION IN COMBINATION WITH NUCLEOSIDE ANALOGUES OR AS MONOTHERAPY] 20-680 NORVIR ABBOTT RITONAVIR 01-MAR-96 (CAPSULE) ABBOTT PARK, IL 100MG (3 P) 60064 ...
Drug Approvals for December 1997 Also provides for the addition of Haemophilus influenzae to the presently approved indication for secondary bacterial infections of acute bronchitis Application #: 020522 Efficacy Supplement#: 004 Type: SE1 to Original New Drug Application Approval Date: 17-DEC-97 Trade Name: NUTROPIN AQ Dosage Form: INJECTABLE Applicant: GENENTECH INC Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC...
Cold Remedies: Over-the-Counter Drugs: Merck Manual Home Edition Section Drugs Subject Over-the-Counter Drugs Cold Remedies More than 100 viruses can cause the misery attributed to the common cold, and a cure remains elusive.
Common Cold: Viral Infections: Merck Manual Home Edition Nonprescription Cold Remedies Type Drug Side Effects Analgesics/Antipyretics (relieve aches and pains, reduce fever) - Acetaminophen Minimal - Aspirin Reye's syndrome possible in children with influenza, stomach irritation - Nonsteroidal anti- inflammatory drugs such as ibuprofen and naproxen Stomach irritation Antihistamines (open nasal passages, help relieve sneezing) - ...
Introduction: Allergic Reactions: Merck Manual Home Edition Section Immune Disorders Subject Allergic Reactions Introduction Allergic reactions (hypersensitivity reactions) are inappropriate immune responses to a normally harmless substance.
Index: BR: Merck Manual Home Edition examination of Selected Screening Schedule for Adults Cancer Screening Recommendations Gynecologic Evaluation: Gynecologic Examination How to Perform a Breast Self-Examination Cancer: Screening lump(s) in Cancer: Symptoms mammography of Selected Screening Schedule for Adults Diagnosis: Screening Cancer Screening Recommendations Mammography: Screening for Breast Cancer Cancer:...
THE MERCK MANUAL OF GERIATRICS, Index B dementia 363 Bentiromide test 1103 Benzodiazepines (see also specific drugs) adverse effects of 325 , 340 aging effect on 61-62 in agitation 356 alcohol interaction with 335 in alcohol withdrawal 338 complications of 456 delirium with 352t in dementia-related behavior disorders 375 dependence on 340 driving and 236 for dying patient 121-122 for gastrointestinal endoscopy 1007 in...
Cold Remedies: Over-the-Counter Drugs: Merck Manual Home Edition Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
Introduction: Allergic Reactions: Merck Manual Home Edition Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
Common Cold: Viral Infections: Merck Manual Home Edition Nonprescription Cold Remedies Type Drug Side Effects Analgesics/Antipyretics (relieve aches and pains, reduce fever) - Acetaminophen Minimal - Aspirin Reye's syndrome possible in children with influenza, stomach irritation - Nonsteroidal anti- inflammatory drugs such as ibuprofen and naproxen Stomach irritation Antihistamines (open nasal passages, help relieve sneezing) - ...
