Approved Products_2004.xls Number A pproval Date Trade Name Generic/ Chemical name Indication Company 1 Oct- 82 Humulin Human Insulin Type I Diabetes Lilly / Genentech 2 Oct- 85 Protro pin Human Growth Hormone Hypoptuitary dwarfism Genentech 3 Jun- 86 Intron A Interferon Al pha 2B Hairy Cell Leukemia Schering Plough / Biogen 4 Jun- 86 OKT- 3 Anti CD3 Mab Acute Trans plant Rejection JNJ / OrthoBiotech 5 Jun- 86...
author: Reijer
Database S S - investigational drugs, therapies and vaccines # - 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 From this page you may order documents with information covering investigational products.
Database H H - investigational drugs, therapies and vaccines # - 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 From this page you may order documents with information covering investigational products.
http://www.gene.com/gene/ir/financials/annual-reports/2003/financials/form10k.pdf We own or have rights to various copyrights, trademarks and trade names used in our business including the following: Activase ® (alteplase, recombinant) tissue- plasminogen activator; Avastin ’ (bevacizumab) anti- VEGF antibody; Cathflo ® Activase ® (alteplase for catheter clearance); Herceptin ® (trastuzumab) anti- HER2 antibody; Lucentis ’ ...
http://www.gene.com/gene/ir/financials/annual-reports/2003/financials/form10k.pdf page 5
http://www.fda.gov/cder/orange/appendix_a.txt ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
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:...
DDPA August 1996 74-635 NAPROXEN SODIUM NOVOPHARM NAPROXEN SODIUM 20-AUG-96 (TABLET) SCARBOROUGH, ONTARIO 220MG CANADA (NONSTEROIDAL ANTI-INFLAMMATORY) 74-570 ACYCLOVIR ROXANE LABS ACYCLOVIR 30-AUG-96 (CAPSULE) COLUMBUS, OH 200MG 43216 (ANTIVIRAL) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 08-678 ISONIAZID EON MANUFACTURE LABS ISONIAZID 01-AUG-96 (TABLET) LAURELTON, NY 100MG 11413 300MG (LABELING...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, GANTANOL to LYSODREN Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS GANTANOL to LYSODREN Trade Name Generic GANTANOL Sulfamethoxazole GANTRISIN Sulfisoxazole GARAMYCIN Gentamicin GEOCILLIN Carbenicillin GLUCOPHAGE Metformin GLUCOTROL Glipizide GRIFULVIN V Griseofulvin GRISACTIN Griseofulvin HALCION Triazolam HALDOL Haloperidol HALDRONE Paramethasone HALOTESTIN...
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...
Products Home | Search | Contact - - Products | R&D | News | About | Careers | Investors - Products Access to Medicines Women's Health Conditions & Diseases - For additional navigation you must have JavaScript enabled.Humatrope ® (somatropin rDNA origin for injection, Lilly) Osteoporosis Evista ® (raloxifene hydrochloride) Sepsis Xigris ® ...
http://www.lilly.com/about/citizenship/LillyCCR2004_0705.pdf S.) Humalog ® insulin lispro injection (rDNA origin) for treatment of type 1 and type 2 diabetes Humatrope ® somatropin (rDNA origin) for injection for growth failure caused by pediatric growth hormone deficiency, for replacement therapy for adult growth hormone deficiency, for short stature caused by Turner syndrome, for idiopathic short stature Humulin ®...
http://www.lilly.com/about/citizenship/LillyCCR2004_0705.pdf page 10
http://www.lilly.com/investor/annual_report/lillyar2004complete.pdf page 96
Endocrinologic and Metabolic Drugs Advisory Committee Meetings FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - Endocrinologic and Metabolic Drugs Advisory Committee Meetings List of Tentative Meeting Dates for All CDER Advisory Committees List of Committee Members Committee Charter CDER Contacts Current Year Meeting Information 2004 FDA Advisory Committee Calendar - Meeting information includes...
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - - EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 (SE1 -SE7)* and EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 (SE8)* - GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION FLUOXETINE...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, GANTANOL to LYSODREN Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS GANTANOL to LYSODREN Trade Name Generic GANTANOL Sulfamethoxazole GANTRISIN Sulfisoxazole GARAMYCIN Gentamicin GEOCILLIN Carbenicillin GLUCOPHAGE Metformin GLUCOTROL Glipizide GRIFULVIN V Griseofulvin GRISACTIN Griseofulvin HALCION Triazolam HALDOL Haloperidol HALDRONE Paramethasone HALOTESTIN...
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...
1997 Warning Letters and Notice of Violation 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 1997 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office
Welcome to Lilly UK - Humatrope Generic Name: - Somatropin - Legal Category: - POM Product Strengths: - 1.33mg, 6mg, 12mg, 24mg - Product Forms: - Vials, Cartridges - Presentations: - 1.33mg (4iu) x 1 Vial 12mg (36iu) x 1 Cartridge 24mg (72iu) x 1 Cartridge 6mg (18iu) x 1 Cartridge - - Product Codes - PIP Code - EAN Code - Licence 1.33mg x 1 Vial - 020 - 2028 - 5014602101077 - PL 0006/0237...
Welcome to Lilly UK - Humatrope (Somatropin ) Summary of Product Characteristics Click on one of the following links to go to the Electronic Medicine CompendiumHumatrope Patient Information Leaflets Click on one of the following links to go to the Electronic Medicine...
Welcome to Lilly UK - Drug Name Generic Name Therapy Area Axid Nizatidine Gastrointestinal Disease Celance Pergolide mesilate Parkinson's disease Cialis Tadalafil Erectile Dysfunction Distaclor MR / Distaclor Cefaclor Infectious Diseases Evista Raloxifene Hydrochloride Osteoporosis Forsteo Teriparatide Osteoporosis Gemzar Gemcitabine Hydrochloride Cancer Humalog Human Insulin Analogue Diabetes Humapen...
Reference Listed Drug Labeling Approved in February 2001 letter label meropenem for injection 50-706 S-007 SUPRAX letter label cefixime oral suspension 50-622 S-014 VANCOCIN HCL letter label vancomycin hydrochloride capsules 50-606 S-014 ZYVOX letter label linezolid tablets linezolid injection linezolid for oral suspension 21-130 21-131 21-132 S-001 S-001 S-001 Feb 8 AVANDIA letter label rosiglitazone maleate tablets 21-071 S-006...
author: USERNAME
C:\labeling\humotropes032ap.doc DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 19- 640/ S- 032 Eli Lilly and Company Attention: Jeffrey T
author: Kati Johnson
C:\labeling\humotropes032ap.doc page 1
author: Kati Johnson
