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...
21214_Rescula.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Rescula (Unoprostone Isopropyl Ophthalmic Solution) Company:- CIBA Vision Corporation Application No.:- 21-214 Approval Date:-8/3/2000 - Approval Letter(s) - Printed Labeling - Medical Review(s) - Part 1 - Part 2 - Chemistry Review(s) - Pharmacology Review(s) Part 1 -...
author: Paul Stauffer
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) Lopinavir/ritonavir...
author: OLIVERN
NMEs Approved in CY 2000 NMEs Approved in Calendar Year 2000 NDA Number Generic Name- Trade Name Dosage Form Applicant - --- Classification- Approval Date 20-989 Cevimeline HCl Evoxac Capsule Snowbrand 1S 01-11-2000 21-014 Oxcarbazepine Trileptal Tablet Novartis Pharms 1S 01-14-2000 20-987 Pantoprazole Sodium Protonix Tablet Wyeth Ayerst 1S 02-02-2000 21-107 Alosetron HC1 Lotronex Tablet Glaxo Wellcome 1P 02...
author: Susan Daugherty
FDA Drug Approvals List August 2000 Original Application #: 021197 Approval Date: 11-AUG-00 Trade Name: CETROTIDE Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: ASTA MEDICA INC Active Ingredient(s): CETRORELIX OTC/RX Status: RX Indication(s): For the prevention of premature LH surges in women undergoing controlled ovarian stimulation Original Application #: 021128 Approval Date: 01-AUG-00...
RESCULA? NDA 21- 214 Rescula (unoprostone isopropyl ophthalmic solution) 0.15% Page 1 of 6 RESCULA Rx Only (unoprostone isopropyl ophthalmic solution) 0.15% DESCRIPTION Unoprostone Isopropyl is a docosanoid, a structural analogue of an inactive biosynthetic cyclic derivative of arachidonic acid, 13, 14- dihydro- 15- keto- prostaglandin F2
author: CDER USER
RESCULA? page 4
author: CDER USER
RESCULA? page 3
author: CDER USER
RESCULA? page 1
author: CDER USER
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt LISINOPRIL CRUDE AS MFG IN COURBEVOIE AND HAM FRANCE 14537 19-Nov-99 FUJISAWA PHARMACEUTICAL CO LTD FK8453 DRUG SUBSTANCE AS MFG IN HYOGO AND OSAKA JAPAN 14538 09-Nov-99 SICOR DE MEXICO SA DE CV AMCINONIDE AS MFG IN LERMA MEXICO 14539 18-Nov-99 "UQUIFA ITALIA, S.P.A." CLINDAMYCIN HYDROCHLORIDE USP AS MFG IN MILAN ITALY 14540 18-Nov-99 DIOSYNTH BV TESTOSTERONE UNDECANOATE AS MFG IN...
Contents Vol. 25, No. 8, 2002 Contents Leading Articles Nonsteroidal Anti- Inflammatory Drugs and Reversible Female Infertility: Is There a Link
author: Adis International Limited
subject: Drug Safety
Pharmaceutical Product List O-R - Novartis.com Search Novartis.com - Go Novartis.com Home Products Pharmaceutical Best Sellers Pharmaceuticals CIBA Vision Animal Health Over the Counter Infant and Baby Medical Nutrition Diseases & Conditions About Novartis Investor Relations Media Relations Careers Corporate Citizenship Business Development Our Mission Our Businesses Leadership & Governance Research & Development Foundations...
PDF cover 0502.qxd The grant of Supplementary Protection Certificates (SPCs) to R- Tech Ueno and Altana is reported in this week's Patents and Designs Journal (PDJ) from the UK Patent Office, alongside a notice relating to entry into force of a Janssen SPC.isopropyl unoprostone to Fujisawa, whose ...
author: LEmson
PDF cover 0502.qxd page 1
author: LEmson
2000 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 2000 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office
Pharmaceutical Product List O-R - Novartis.com - OrstanormA®, DihydergotA® - (dihydroergotamine mesylate) Used in treatment of orthostatic hypotension and migraine - ParlodelA® / SROA® - (bromocriptine mesylate, USP) Used in treatment of Parkinson's disease - RegitinA® - (phentolamine methanesulfonate-adrenergic receptor blocker) Used in treatment for the management of hypertensive episodes associated...
http://www.fujisawa.co.jp/ir/ar2003/2003h_1.pdf ANNUAL REPORT 2003 1 Fujisawa Pharmaceutical Co., Ltd., headquartered in Japan, is a research- driven pharmaceutical company with a firm commitment to innovative research in its quest to satisfy unmet medical needs and contribute to the progress of medical care
01FS_ONE.QXD 16Novartis Group Therapeutic areaProject/ compoundGeneric nameIndication Cardiovascular, SPP100– Hypertension metabolism, LAF237… Type- II diabetes endocrinology DiovanvalsartanCongestive heart failure valsartan Post- and pre- myocardial infarction Navigator* … Progression to type- II diabetes Sandostatin LAR octreotide acetate Diabetic retinopathy, other indications...
author: Imfeld
duplicates:http://www.novartis.com/annual_reports/2002/en/download/pharma_dvp.pdf http://www.novartis.com/annual_reports/2002/en/download/pharma_dvp.pdf
01FS_ONE.QXD page 1
author: Imfeld
duplicates:http://www.novartis.com/annual_reports/2002/en/download/pharma_dvp.pdf http://www.novartis.com/annual_reports/2002/en/download/pharma_dvp.pdf
01FS_ONE.QXD Caring and Curing Annual Report 2002 ƒmolecules for medicines ƒ Martin Klumpp, PhD, Lukas Leder, PhD, and Aline Tirat, Novartis Lead Discovery Center, Basel, Switzerland Novartis Group 1 Financial Highlights2 News in 20023 Letter from Daniel Vasella5 Amazing Patient Stories9 Division and Product Review Pharmaceuticals14 Joining Forces in the Quest for Cures22 Consumer...
author: Imfeld
duplicates:http://www.novartis.com/downloads/annual_reports/annualreport_2002.pdf http://www.novartis.com/annual_reports/2002/en/download/annualreport_2002.pdf http://www.novartis.com/downloads/annual_reports/annualreport_2002.pdf http://www.novartis.com/annual_reports/2002/en/download/annualreport_2002.pdf http://www.novartis.com/downloads/annual_reports/annualreport_2002.pdf
http://www.novartis.com/downloads/pharma_dvp.pdf 16 Novartis Group Therapeutic area Compound Generic name Indication Cardiovascular SPP100 aliskiren Hypertension and metabolism LAF237 TH Type- II diabetes Diovan valsartan Congestive heart failure valsartan Post- and pre- myocardial infarction Navigator* TH Progression to type- II diabetes Sandostatin LAR octreotide acetate Diabetic retinopathy, other indications Lot el 0, 20 TH...
duplicates:http://www.novartis.com/downloads/pharma_dvp.pdf http://www.novartis.com/downloads/pharma_dvp.pdf
http://www.novartis.com/downloads/pharma_dvp.pdf page 1
duplicates:http://www.novartis.com/downloads/pharma_dvp.pdf http://www.novartis.com/downloads/pharma_dvp.pdf
Novartis Fact Sheet Final Think what's possible
author: Mark Lobello
duplicates:http://www.novartis.com/downloads/ir_us_fact_2001.pdf http://www.novartis.com/downloads/ir_us_fact_2001.pdf
Novartis Fact Sheet Final page 3
author: Mark Lobello
duplicates:http://www.novartis.com/downloads/ir_us_fact_2001.pdf http://www.novartis.com/downloads/ir_us_fact_2001.pdf
141384_JB_e_S001_013_OK Sector and Product Review 18 Compounds in development The Novartis pipeline represents a broad stream of promising future products, with 50 projects in Phase II and beyond as of December 2001, including both new molecular entities and additional indications or formulations for marketed products
author: Cartier
duplicates:http://www.novartis.com/downloads/sector_prod_review.pdf http://www.novartis.com/downloads/sector_prod_review.pdf
