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 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 SERTRALINE HYDROCHLORIDE PFIZER 19-839 SE1 045 22-Jan-02 7-Feb-03 12.5 Provides for the use of Zoloft (sertraline hydrochloride) Tablets for the treatment of social anxiety disorder as a new indicationSERTRALINE HYDROCHLORIDE PFIZER 20-990 SE1 011 22-Jan-02 7-Feb-03 12.5 Provides for the use of Zoloft (sertraline hydrochloride) Oral Concentrate...
20990_Zoloft.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Zoloft (Sertraline Hydrochloride) Oral Comcentrate Company:- Pfizer Pharmaceuticals Application No.:- 020990 Approval Date:-12/07/99 - Approval Letter(s) - Printed Labeling - Medical Review(s) - Chemistry Review(s) & Microbiology Review(s) - Clinical Pharmacology...
author: Paul Stauffer
19-839S026_Zoloft.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Zoloft (Sertraline Hydrochloride) Tablets Company:- Pfizer Inc
author: Paul Stauffer
FDA Drug Approvals List October 2001 - Drug Approvals for October 2001 Definitions and Notes Original New Drug Applications Original Application #: 021356 Approval Date: 26-OCT-01 Trade Name: VIREAD Chemical Type: 1 Therapeutic Potential: P Dosage Form: TABLET Applicant: GILEAD SCIENCES INC Active Ingredient(s): TENOFOVIR DISOPROXIL FUMARATE OTC/RX Status: RX Indication(s): For use in combination with other...
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:...
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s SERTRALINE PFIZER PHARMS 19-839 SE1 039 1-Feb-01 16-May-02 - 15.4 Provides for the use of Zoloft Tablets in the treatment of Premenstrual Dysphoric Disorder (PMDD)SERTRALINE PFIZER PHARMS 20-990 SE1 007 1-Feb-01 16-May-02 - 15.4 Provides for the use of Zoloft Oral Concentrate in the treatment of Premenstrual Dysphoric Disorder (PMDD)
author: Darlene Norris
FDA Drug Approvals List- April 1999 Original Application #: 050760 Approval Date: 15-APR-99 Trade Name: AMOXIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: SUSPENSION Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): AMOXICILLIN OTC/RX Status: RX Indication(s):For the use of Amoxil for oral suspension 200mg/5mL and 400mg/5mL in divided doses q12h Original Application #: 020924 Approval Date:...
FDA Drug Approvals List December 1999 Original Application #: 020965 Approval Date: 03-DEC-99 Trade Name: LEVULAN KERASTICK Chemical Type: 1 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: ELINES, INCORPORATED Active Ingredient(s): AMINOLEVULINIC ACID HCL OTC/RX Status: RX Indication(s): For the use with a blue light irradiation using the BLU-U Illuminator for the photodynamic therapy of actinic keratoses of...
FDA Drug Approvals List November 2000 Active Ingredient(s): VINORELBINE TARTRATE OTC/RX Status: RX Application #: 018936 Labeling Supplement #: 063 To Original New Drug Application Approval Date: 28-NOV-00 Trade Name: PROZAC Dosage Form: CAPSULE Applicant: LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO Active Ingredient(s): FLUOXETINE HYDROCHLORIDE OTC/RX Status: RX Application #: 018936 Labeling Supplement #:...
DDPA June 1995 74-423 CAPTOPRIL MOVA CAPTOPRIL 07-JUN-95 (TABLET) CAGUAS, PR 12.5MG 00725 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 17-911 CLINORIL MERCK SULINDAC 01-JUN-95 (TABLET) WEST POINT, PA 150MG 19486 200MG (LABELING REVISION -- PRECAUTIONS; ADVERSE REACTIONS) 16-744* NORIDAY 1+50-FE SYNTEX FERROUS FUMARATE 02-JUN-95 (TABLET) PALO...
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 October 1997 Drug Approvals for October 1997 Definitions and Notes October 1997 Original New Drug Applications Original Application #: 020755 Approval Date: 31-OCT-97 Trade Name: CAVERJECT Chemical Type: 5 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PHARMACIA AND UPJOHN CO Active Ingredient(s): ALPROSTADIL OTC/RX Status: RX Indication(s): Provides for an aqueous formulation for...
Drug Approvals for July 1997 Drug Approvals for July 1997 Definitions and Notes July 1997 Original New Drug Applications Original Application #: 020701 Approval Date: 31-JUL-97 Trade Name: CRINONE Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: COLUMBIA RESEARCH LABORATORIES INC Active Ingredient(s): PROGESTERONE OTC/RX Status: RX Indication(s): Treatment of secondary amenorrhea Original...
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...
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...
Selective serotonin reuptake inhibitors (SSRIs) for postpartum depression - [Medication] - Quest Diagnostics Patient Health Of the various SSRIs, Sertraline (Zoloft) is the first-choice medication because it is passed on to breast-feeding infants in nearly undetectable amounts and has no known infant side effects.
Reducing Medication Costs - Quest Diagnostics Patient Health Library Reducing Medication Costs Topic Overview How can I lower my medication costs?
Antidepressants for cancer pain - [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 Antidepressants for cancer pain - [Medication] - Quest Diagnostics Patient Health Library Antidepressants for cancer pain - [Medication] - Quest Diagnostics Patient Health Library Cancer, Amitriptyline, amitriptyline HCl, amitriptyline hydrochloride, Antidepressant,...
Selective serotonin reuptake inhibitors for panic disorder - [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 Selective serotonin reuptake inhibitors for panic disorder - [Medication] - Quest Diagnostics Patient Health Library Selective serotonin reuptake inhibitors for panic disorder - [Medication] - Quest Diagnostics Patient Health Library Brain and nerves, Mental...
Selective serotonin reuptake inhibitors (SSRIs) for childhood and adolescent depression - [Medication] - Quest Diagnostics Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Selective serotonin reuptake inhibitors (SSRIs) for childhood and adolescent depression - [Medication] - Quest Diagnostics Selective serotonin reuptake inhibitors (SSRIs) for childhood and adolescent depression - [Medication] - Quest Diagnostics Brain and...
Selective serotonin reuptake inhibitors for depression and pain after a stroke - [Medication] - Quest Diagnostics Patient Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Selective serotonin reuptake inhibitors for depression and pain after a stroke - [Medication] - Quest Diagnostics Patient Selective serotonin reuptake inhibitors for depression and pain after a stroke - [Medication] - Quest Diagnostics Patient Brain and...
