Generic Names of Some Trade Name Drugs, THE MERCK MANUAL OF HEALTH & AGING Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs -~ Generic Names of Some Trade Name Drugs - Generic Names of Some...
Some Trade Names of Generic Drugs, THE MERCK MANUAL OF HEALTH & AGING Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs-~ Generic Names of Some Trade Name Drugs - Some Trade Names of...
Prostatitis: Prostate Disorders: 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...
Chronic Obstructive Pulmonary Disease: 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...
Nongonococcal Urethritis and Chlamydial Cervicitis: Sexually Transmitted Diseases: 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...
Crohn's Disease: Inflammatory Bowel Diseases: 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...
Gonorrhea: Sexually Transmitted Diseases: 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...
Bronchitis: 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...
Drug Approvals - Q Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Quinapril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Teva Pharmaceuticals 75-504 5/30/03 - - - Quinapril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Tentatively Approved Andrx Pharmaceuticals 76-049 6/11/03 - - - Quinapril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx, Tentatively Approved...
Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
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...
2003 Warning Letters and Untitled Letters to Pharmaceutical Companies Food and Drug Administration • Center for Drug Evaluation and Research Compliance Activities Search Warning Letters and Untitled Letters to Pharmaceutical Companies 2003 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office
author: STAUFFERP
Reference Listed Drug Labeling Approved in April 2002 Apr 3 ARGATROBAN letter label argatroban injection 20-883 SE1 004 Efficacy claim: For use in patients undergoing percutaneous coronary interventions (PCI) who have or are at risk for heparin-induced thrombocytopenia Apr 5 DIOVAN letter label valsartan tablet 21-283 SE8 002 Efficacy claim: Provides for an alternative starting dose of 160 mg Apr 9 MEGACE letter -- megestrol acetate...
author: USERNAME
Report to the Nation: Drug Review Priority new drug approvals (N=NME) Abacavir/lamivudine/zidovudine (Trizivir) Alosetron (Lotronex) (N) Arsenic trioxide (Trisenox) (N) Atovaquone/proquanil (Malarone) Bexarotene (Targetin) Budesonide (Pulmicort) Didanosine (Videx EC) Gentuzumab ozogamicin (Mylotarg) (N) Levobetaxolol (Betaxon) Levofloxacin (Quixin) Linezolid (Zyvox) (3 NDAs approved, 1 as NME) (N)...
author: OLIVERN
N:\Lisa\SANTEN\Nda21199\02n21199let.doc Food and Drug Administration Rockville MD 20857 NDA 21- 199/ S- 002 Santen Incorporated Attention: Nancy Yee Regulatory Affairs Specialist II 555 Gateway Drive Napa, CA 94558 Dear MsQuixin (levofloxacin ...
author: Lisa Hubbard
N:\Lisa\SANTEN\Nda21199\02n21199let.doc page 1
author: Lisa Hubbard
C:\LORI\SANTEN\21199 S3 AP 6-3-02 phys sample .DOC DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 NDA 21- 199/ S- 003 Santen Incorporated Attention: Lisa Ann Suchar, PhQuixin ...
author: Lori Gorski
C:\LORI\SANTEN\21199 S3 AP 6-3-02 phys sample .DOC page 1
author: Lori Gorski
Santen-Quixin Press Release-March 1, 2000 - - SANTEN PHARMACEUTICAL SUBMITS NEW DRUG APPLICATION FOR QUIXIN ...
Santen- Quixin Press Release-August 31, 2000 - - - ALLERGAN FILES SUIT AGAINST SANTEN FOR IMMEDIATE ...
Santen-Quixin Press Release-August 21, 2000 - - - SANTEN RECEIVES FDA APPROVAL OF QUIXIN™, ANTI-INFECTIVE ...
US News Room at Santen - - - Today's Allergy Market One of the most common allergy ...
Welcome to Santen Incorporated The beautiful symmetry of the circle, like that of the human eye, is the essence of our vision. The ability to see, so integral to every aspect of our lives, must be safeguarded. Santen understands ...
FY 2000 USER FEE PRIORITY APPROVALS FY 2000 USER FEE PRIORITY APPROVALS NDA# - Trade Name (Generic Name) Dosage Form Applicant Date of Approval Class Indication(s) 21-087 Tamiflu (oseltamivir phosphate) Capsules Hoffmann-La Roche 27-Oct-99 1P Tamiflu is indicated as a treatment of influenza A and B
author: Brenda Harmon
FDA Drug Approvals List August 2000 - Drug Approvals for August 2000 Definitions and Notes Original New Drug Applications Original Application #: 021110 Approval Date: 25-AUG-00 Trade Name: RAPAMUNE Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: WYETH-AYERST RESEARCH Active Ingredient(s): SIROLIMUS OTC/RX Status: RX Indication(s): For the prophylaxis of organ rejection in patients receiving...
