http://www.biosis.org/ts/media/cdjournals/gazettenews/2002/CPG_News_0219.pdf week 0219 10 May 2002 Mirtazapine formulation patents are the subject of a dispute between Akzo and Barr Laboratories....
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...
21-208_Remeron SolTab Tablets Food and Drug Administration • Center for Drug Evaluation and Research Title Search Remeron SolTab (Mirtazapine) Orally Disintegrating Tablets Company:--Organon Inc
author: USERNAME
NDA Approvals for Calendar Year 2001 NDA APPROVALS FOR CALENDAR YEAR 2001 Updated through December 31, 2001 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21-252 Canasa Mesalamine Axcan Scandipharm 5 P 05-Jan-01 21-208 Remeron SolTab Mirtazapine Organon 3 S 12-Jan-01 21-227 Cancidas Caspofungin Acetate Merck Research Labs 1 P 26-Jan-01 21-261...
author: Brenda Harmon
Report.PDF page 4
author: default
Prescription and OTC Drug Product List 1/2001 Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 1: January 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL - ADD - ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE BISOPROLOL...
FDA Drug Approvals List January 2001 - Drug Approvals for January 2001 Definitions and Notes Original New Drug Applications Original Application #: 021208 Approval Date: 12-JAN-01 Trade Name: REMERON SOLTAB Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET, ORALLY DISINTEGRATING Applicant: ORGANON INC Active Ingredient(s): MIRTAZAPINE OTC/RX Status: RX Indication(s): For the treatment of...
Cima Labs, Inc. CIMA works with pharmaceutical companies to develop and manufacture their products as ODTs, in addition to developing proprietary products.
BioPortfolio Limited Lescol – US ex-manufacturer pricing comparison 154 Table 15: ‘Generic defense’ strategies – change in total US sales four quarters following generic incursion across six franchises 165 Table 16: Remeron SolTab US sales as a percentage of total molecule (mirtazapine) sales (Q3 2002 – Q4 2003) 166 LIST OF FIGURES Figure 1: Combination as a lifecycle...
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http://www.akzonobel.com/misc/downloadabledoc.asp?tp=1&id=UDUTkX%2BEuYg%3D&number=1&l=English Earnings burdened by currencies, pensions, and Remeron ® ; restructurings paying off Third- quarter sales of EUR 3.3 billion were 7% lower than last yearRemeron SolTab ™ still holding up NuvaRing ® – gathering momentum Puregon ® and Livial ® – growing ° Intervet – mixed performance ° Diosynth – impacted...
http://www.akzonobel.com/misc/downloadabledoc.asp?tp=1&id=UDUTkX%2BEuYg%3D&number=1&l=English page 7
http://www.akzonobel.com/misc/downloadabledoc.asp?tp=1&id=UDUTkX%2BEuYg%3D&number=1&l=English page 6
http://www.akzonobel.com/misc/downloadabledoc.asp?tp=1&id=DFQQYsBgogA%3D&number=1&l=English These losses mainly concern impairment and restructuring costs of the Organon production site in West Orange, New Jersey, and the settlement in the Remeron ® court case with generic drug manufacturers
http://www.akzonobel.com/misc/downloadabledoc.asp?tp=1&id=DFQQYsBgogA%3D&number=1&l=English page 7
Pharma 56 Thanks to our diverse portfolio, we not only produce various drugs to aid family planning but also manufacture chemicals used in diapers and flame retardantsRemeron ® antidepressant, lost its exclusivity in the URemeron ® sales in other countries and promotion of ...
author: Aart
Pharma page 2
author: Aart
Presentation T. Wilderbeek LIBERATE study, Livial for alleviation of treatment-induced side effects in breast cancer, 2600 patients, completion 2008 Fall Analyst Meeting Fertility Puregon Organon ranking # 2 in a EUR 1.1 billion market • • Puregon / Follistim, recombinant FSH, 2002 sales of EUR 356 million (lyophilized, liquid and as Puregon Pen) Follistim Pen USA: in discussion with FDA Japan:...
author: Joop van Orsouw
