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...
Prescription and Over-the-Counter Drug Product List: 12/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> + MIKART 750MG;50MG;40MG N40496 001 DEC 23, 2003 DEC NEWA ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE TABLET; ORAL DARVOCET A500 >D> + AAIPHARMA 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA >A> + 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA...
http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA...
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 VALACYCLOVIR HYDROCHLORIDE GLAXOSMITHKLINE 20-550 SE1 005 24-Apr-97 1-Apr-03 71.3 Provides for the use of Valtrex (valacyclovir hydrochloride) 500 mg Caplets for the suppression of recurrent genital herpes in HIV-infected individualsVALACYCLOVIR HYDROCHLORIDE GLAXOSMITHKLINE 20-550 SE1 019 1-Nov-02 29-Aug-03 9.9 Provides for the use of ...
1999 Warning Letters and Untitled Letters to Pharmaceutical Companies DDMAC 1/21/99 1/26/99 Prograf (tacrolimus) capsules Fujisawa USA DDMAC 1/4/99 1/11/99 Remeron (mitrazapine) tablets Organon DDMAC 1/5/99 1/14/99 Risperdal (risperidone) tablets and oral solution Janssen Research DDMAC 1/5/99 1/14/99 Trivora, Zovia, Necon, Levora, Nor-QD Tablets Watson Laboratories DDMAC 1/26/99 2/12/99 February Arava (leflunomide) tablets Hoechst Marion Roussel DDMAC...
FDA Drug Approvals List June 2001 PERRIGO COMPANY Active Ingredient(s): MONOXIDIL OTC/RX Status: RX Original Abbreviated Application # 075750 Approval Date: 8-JUN-01 Trade Name: DOXAZOSIN MESYLATE Dosage Form: TABLET Applicant: SIDMAK LABORATORIES, INC Active Ingredient(s): DOXAZOSIN MESYLATE OTC/RX Status: RX Original Abbreviated Application # 075502 Approval Date: 05-JUN-01 Trade Name: CLOTRIMAZOLE AND...
Prescription and OTC Drug Product List 3/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ALBUTEROL SULFATE AEROSOL, METERED; INHALATION PROVENTIL-HFA -D- + 3M EQ 0.09MG BASE/INH N20503 001 AUG 15, 1996 MAR CTEC -A- BX + EQ 0.09MG BASE/INH N20503 001 AUG 15, 1996 MAR CTEC VENTOLIN HFA -D- + GLAXOSMITHKLINE EQ 0.09MG BASE/INH N20983 001 APR 19, 2001 MAR CTEC -A- BX + EQ 0.09MG BASE/INH N20983 001 APR 19, 2001 MAR CTEC...
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s VALACYCLOVIR HYDROCHLORIDE GLAXOSMITHKLINE 20-550 SE1 016 14-Nov-01 9-Sep-02 - 9.8 Provides for the use of Valtrex (valacyclovir hydrochloride) for the treatment of cold sores (herpes labialis) in adult and adolescent patients 12 years of age and older
author: Darlene Norris
Drug Approvals for April 1997 Drug Approvals for April 1997 Definitions and Notes April 1997 Original New Drug Applications Original Application #: 020619 Approval Date: 17-APR-97 Trade Name: BETOPTIC PILO Chemical Type: 4 Therapeutic Potential: S Dosage Form: SUSPENSION/DROPS Applicant: ALCON LABORATORIES INC Active Ingredient(s): BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE OTC/RX Status: RX...
Drug Approvals January 1997 Drug Approvals for January 1997 Definitions and Notes January 1997 Original New Drug Applications Original Application #: 050733 Approval Date: 30-JAN-97 Trade Name: ZITHROMAX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PFIZER INC Active Ingredient(s): AZITHROMYCIN OTC/RX Status: RX Indication(s): Treatment of patients with community-acquired...
DDPA December 1995 Drug and Device Approvals-December 1995 December 1995 - FDA Drug and Device Product Approvals ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-628 INVIRASE ROCHE SAQUINAVIR MESYLATE 06-DEC-95 (CAPSULE) NUTLEY, NJ EQ 200MG BASE (1 P, AA*, E**, H***) 07110 (ANTIVIRAL) [TREATMENT OF ADVANCED HIV INFECTION IN SELECTED PATIENTS IN COMBINATION WITH NUCLEOSIDE ANALOGUES] 19-835...
DDPA June 1995 DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER TRADE NAME APPLICANT ACTIVE INGREDIENT(S) APPROVAL DATE (DOSAGE FORM) STRENGTH(S) (CLASSIFICATION) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-132 IMITREX GLAXO WELLCOME SUMATRIPTAN SUCCINATE 01-JUN-95 (TABLET) RES TRIANGLE PK, NC EQ 25MG BASE (3 S) 27709 EQ 50MG BASE EQ...
Drug Approvals October 1996 Drug Approvals for October 1996 Definitions and Notes October 1996 Original New Drug Applications Original Application #: 019821 Approval Date: 28-OCT-96 Trade Name: SORIATANE Chemical Type: 2 Therapeutic Potential: S Dosage Form: CAPSULE Applicant: HOFFMAN-LAROCHE Active Ingredient(s): ACITRETIN OTC/RX Status: RX Indication(s): Treatment of severe psoriasis Original Application #:...
Drug Approvals for September 1997 The development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program Original Application #: 020857 Approval Date: 26-SEP-97 Trade Name: COMBIVIR Chemical Type: 4 Therapeutic Potential: P Dosage Form: TABLET Applicant: GLAXO WELLCOME INC Active Ingredient(s): LAMIVUDINE; ZIDOVUDINE OTC/RX Status: RX Indication(s): Treatment...
Herpes Zoster Ophthalmicus: Corneal 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...
Shingles: Viral Infections: 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...
Chickenpox: Viral Infections: 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...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, TACARYL to ZYPREXA Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS TACARYL to ZYPREXA Trade Name Generic TACARYL Methdilazine TACE Chlorotrianisene TAGAMET Cimetidine TALWIN *Pentazocine TAMBOCOR Flecainide TAMIFLU Oseltamivir TAPAZOLE Methimazole TASMAR Tolcapone TAVIST Clemastine TAXOL Paclitaxel TAZICEF Ceftazidime TAZIDIME Ceftazidime TEGISON Etretinate...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs. Salmeterol to Zolpidem Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Salmeterol to Zolpidem Generic Trade Name Salmeterol SEREVENT Salsalate DISALCID, SALFLEX Saquinavir FORTOVASE Sargramostim LEUKINE Secobarbital SECONAL Selegiline ELDEPRYL Selenium SELSUN Sertraline ZOLOFT Sibutramine MERIDIA Sildenafil VIAGRA Silver sulfadiazine SILVADENE Simethicone MYLICON...
Flamel Technologies, Inc info@flamel.com Home | Company | Technologies and Products | Investor Relations | Press Releases | Contact - Medusa Platform ---- Medusa Pipeline Micropump Platform ---- Micropump Pipeline Comprehensive Pipeline Micropump Products Genvir™ (controlled-release acyclovir) Acyclovir The Company is developing Genvir,™ a controlled-release formulation of acyclovir for the...
Herpes Simplex Virus Infections: Viral Infections: 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...
Antivirals for shingles - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Antivirals for shingles - [Medication] - Quest Diagnostics Patient Health Library Antivirals for shingles - [Medication] - Quest Diagnostics Patient Health Library Brain and nerves, Skin, hair, and nails, acyclovir, antiviral, antiviral agents, Antiviral...
Antiviral medications for genital herpes - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Antiviral medications for genital herpes - [Medication] - Quest Diagnostics Patient Health Library Antiviral medications for genital herpes - [Medication] - Quest Diagnostics Patient Health Library Sexual and reproductive organs, Sexual health, acyclovir,...
Antiviral medications for chickenpox - [Medication] - Quest Diagnostics Patient Health Library Antiviral medications for chickenpox Examples Brand Name Chemical Name Zovirax acyclovir Foscavir foscarnet Famvir famciclovir Valtrex valacyclovir hydrochloride Denavir penciclovir Antiviral medications can be taken by mouth (orally) or given by injection into a vein (intravenous, or IV).
Advances in the treatment of HSV-1 infection - - - - BioNews BioWeb Companies Products BioReports - - - - - Channels Select Channel -------> Channels Home Page BioWeb Search BioNews Search BioNews Topics BioWatch Tracking BioJob Career Bio/Pharma Events BioNewsCast BioCorporate BioReports Indication/Disease BioZak CD-rom BioTechnologies BioExecutive BioEquities/Stocks BioDrug Discovery BioJournal BioAnalysis BioSuppliers...
