Microsoft Word - 20050928.doc Forest Laboratories' growing line of products includes: Lexapro( R) (escitalopram oxalate), an SSRI antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults; Namenda( R)( memantine HCl), an N- methyl- D- aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe Alzheimer...
author: MGieson
Microsoft Word - 20050928.doc page 4
author: MGieson
Teva Pharmaceutical Industries - News and PR Jerusalem, Israel, October 3, 2003 Teva Announces Tentative Approval Of Oxycodone Hydrochloride ER Tablets, 80 Mg Jerusalem, Israel, September 30, 2003 Teva Calls 1.5% Convertible Debentures Due 2005 For Redemption Jerusalem, Israel, September 25, 2003 Massachusetts Attorney General To Bring Action Against 13 Generic Drug Companies For Pricing Practices Jerusalem, Israel,...
What's new at CDER by Date Avastin Information Page New and Generic Drug Approvals Advil Liqui- Gels & Migraine Liqui-Gels (ibuprofen), Wyeth Consumer Didronel (Etidronate Disodium) Tablets, Procter and Gamble Loprox (ciclopirox) Shampoo, Medicis Pharmaceutical Corporation Semprex-D (acrivastine and pseudoephedrine) Capsules, Celltech Pharmaceuticals Fosinopril Sodium Tablets, Eon Labs, Tentative...
author: Paul Stauffer
CDER: Previous News Items, 2004 FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - Previous News Items, 2004 February 6, 2004 -FDA approves Oxycodone Hydrochloride (non combination product) February 5, 2004 FDA approves first-time generic TriLyte (Polyethylene Glycol 3350, Potassium Chloride, Sodium Bicarbonate and Sodium Chloride for Oral Solution)
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 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...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt PROPARACAINE HCL 2712 03-Aug-76 PHARMACIA AND UPJOHN INC "HEPARIN, SODIUM U.S.P." 2716 10-Aug-76 SMITHKLINE CORP "CIMETIDINE AND CIMETIDINE HCL MANUFACTURED IN CORK, IRELAND." 2719 09-Aug-76 PLANTEX LTD CHEM AND PHARM WORKS AMITRIPTYLINE HCL 2726 05-Aug-76 SCHERING AG NORETHINDRONE 2736 19-Jul-76 ROUSSEL-UCLAF "DEXAMETHASONE ACETATE ANHYDROUS USP MANUFACTURED IN VERTOLAYE, FRANCE."...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls 3M PHARMS CORDRAN (FLURANDRENOLIDE) TAPE ORGANICS DIV LA GRANGE INC ESTERIFIED ESTROGENS USP POWDER ORGANICS DIV LA GRANGE INC CONJUGATED ESTROGEN USP POWDER GANES CHEMICALS INC PROPOXYPHENE HYDROCHLORIDE AVENTIS PHARMA SA HYDROCORTISONE USP MALLINCKRODT INC OXYCODONE TEREPHTHALATE SOLMAG S.P.A CLIDINIUM BROMIDE PLIVA PHARMACEUTICAL CHEMICAL FOOD & COSMETIC INDUSTRY...
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004 - TABLET; ORAL Approved 2/28/2003- BACLOFEN 10 mg, 20 mg - 02P-0078/CP1 KLEINFELD, KAPLAN & BECKER - ORALLY DISINTEGRATING TABLETS Approved 2/5/2003- OXYCODONE 5mg, 7.5mg, 10mg ACETAMINOPHEN 300mg - 02P-0105/CP1 LACHMAN CONSULTANT SERVICES - TABLETS Approved 8/6/2002- CARISOPRODOL 350 mg - 02P-0138/CP1 LACHMAN CONSULTANT SERVICES - ORALLY DISINTEGRATING TABLETS Withdrawn 7/25...
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004 - TABLET; ORAL, CAPSULE;ORAL Denied 4/14/2000- ACETAMINOPHEN 500 mg OXYCODONE HYDROCHLORIDE 10 mg - 99P-2798/CP1 KING AND SPALDING - TABLET; ORAL Approved 6/13/2000- ACETAMINOPHEN 500 MG/15 ML OXYCODONE HYDROCHLORIDE 7.5 MG/15 ML - 99P-2776/CP1 KING AND SPALDING - LIQUID; ORAL Denied 6/13/2000- ACETAMINOPHEN 650 MG BUTALBITAL 50 MG - 99P-1657/CP1 MIKART INC
Microsoft Word - 6k_all.doc patent on a combination of Hydrocodone Bitartrate and Ibuprofen. Ibuprofen Tablets, 7.
author: Administrator
Microsoft Word - 6k_all.doc page 14
author: Administrator
ANDA Approvals November 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - November 2001 - - ANDA Number Drug Name Applicant Approval Date 1 75-916 RIMANTADINE HYDROCHLORIDE TABLETS 100 MG COREPHARMA LLC 11/2/01 2 75-682 IBUPROFEN TABLETS, USP 400 MG, 600 MG, AND 800 MG BASF CORPORATION 11/14/01 3 75-347 OMEPRAZOLE DELAYED-RELEASE...
author: USERNAME
FDA Drug Approvals List November 2001 - Drug Approvals for November 2001 Definitions and Notes Original New Drug Applications Original Application #: 021277 Approval Date: 30-NOV-01 Trade Name: AVELOX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: BAYER CORP PHARMACEUTICAL DIV Active Ingredient(s): MOXIFLOXACIN HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the treatment of adults ...
Prescription and OTC Drug Product List 12/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE CAPSULE; ORAL SYNALGOS-DC-A -A- @ WOMEN FIRST HLTHCARE 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN -D- @ WYETH AYERST 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL ANEXSIA 5/325 -D- AA MALLINCKRODT 325MG;5MG N40409...
Prescription and OTC Drug Product List 11/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET; ORAL PERCOCET -A- + ENDO PHARMS 325MG;7.5MG N40434 001 NOV 23, 2001 NOV NEWA -A- + 325MG;10MG N40434 002 NOV 23, 2001 NOV NEWA ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE -A- AB ANABOLIC 325MG;50MG...
Prescription and OTC Drug Product List 10/2001 PEDIATRIC -D- + ASTRAZENECA 80MG/VIAL;0.02MG/VIAL;0.00 1MG/VIAL;5MG/VIAL;0.01MG/V IAL;0.14MG/VIAL;17MG/VIAL; 0.2MG/VIAL;1MG/VIAL;1.4MG/ VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/V IAL N18920 001 SEP 21, 2000 OCT CAHN -A- + NEOSAN PHARMS 80MG/VIAL;0.02MG/VIAL;0.00 1MG/VIAL;5MG/VIAL;0.01MG/V IAL;0.14MG/VIAL;17MG/VIAL; 0.2MG/VIAL;1MG/VIAL;1.4MG/ VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/V IAL...
EVALUATION OF THE NEW YORK STATE ONECARD RX WORKERS COMPENSATION BENEFIT page 77
author: Julia Graffam
duplicates:http://www.quintiles.com/NR/rdonlyres/esnb6djlmpmd267ms6votav3bmvxowbn6p7p3tdm3hpo33qoowyjxa2dtx6ssx4tapmrkojnqv3rxjukkkphpf33g6c/1503.pdf
EVALUATION OF THE NEW YORK STATE ONECARD RX WORKERS COMPENSATION BENEFIT page 75
author: Julia Graffam
duplicates:http://www.quintiles.com/NR/rdonlyres/esnb6djlmpmd267ms6votav3bmvxowbn6p7p3tdm3hpo33qoowyjxa2dtx6ssx4tapmrkojnqv3rxjukkkphpf33g6c/1503.pdf
EVALUATION OF THE NEW YORK STATE ONECARD RX WORKERS COMPENSATION BENEFIT page 72
author: Julia Graffam
duplicates:http://www.quintiles.com/NR/rdonlyres/esnb6djlmpmd267ms6votav3bmvxowbn6p7p3tdm3hpo33qoowyjxa2dtx6ssx4tapmrkojnqv3rxjukkkphpf33g6c/1503.pdf
http://www.paddocklabs.com/forms/secundum/volume_8_4.pdf 3 TRANSITIONING INTO THE NEW MILLENNIUM Over the past fifty years, "modern" pain management has involved the use of relatively conservative approaches using pharmacological agents such as salicylates (aspirin), acetaminophen, opiates (codeine, morphine), NSAIDS (ibuprofen, etc.) and the newer synthetic narcotics (fentanyl, etc.)
Prescription and OTC Drug Product List 12/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 12: December 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE ALBUTEROL SULFATE - ADD - SOLUTION; ORAL SOLUTION; INHALATION - ADD - ZIAGEN ALBUTEROL SULFATE - ADD - + GLAXO WELLCOME EQ 20MG BASE/ML N20978 001 - ADD - @ COPLEY PHARM...
Prescription and OTC Drug Product List 8/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 8: August 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL - ADD - BUTALBITAL, ACETAMINOPHEN AND CAFFEINE MODURETIC 5-50 - ADD - AB...
