Bioniche February 12, 2008 Bioniche Reports Fiscal 2008 Second Quarter February 8, 2008 Bioniche Receives $5 Million Capital Financing Support to Scale-up E.
Bioniche February 12, 2008 Bioniche Reports Fiscal 2008 Second Quarter February 8, 2008 Bioniche Receives $5 Million Capital Financing Support to Scale-up E.
Bioniche February 12, 2008 Bioniche Reports Fiscal 2008 Second Quarter February 8, 2008 Bioniche Receives $5 Million Capital Financing Support to Scale-up E.
Bioniche February 12, 2008 Bioniche Reports Fiscal 2008 Second Quarter February 8, 2008 Bioniche Receives $5 Million Capital Financing Support to Scale-up E.
http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf Barr Laboratories, Inc.Cordarone ® , for recurrent ventricular arrhythmias; DextroStat ® , for narcolepsy and attention deficit disorder; and Luvox ® , used to treat Obsessive Compulsive Disorder.
http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf page 18
http://www.fda.gov/cder/orange/appendix_a.txt 12, CHLORPHENIRAMINE MALEATE (OTC) CODOXY, ASPIRIN CODRIX, ACETAMINOPHEN COGENTIN, BENZTROPINE MESYLATE COGNEX, TACRINE HYDROCHLORIDE COL-PROBENECID, COLCHICINE COLAZAL, BALSALAZIDE DISODIUM COLBENEMID, COLCHICINE COLD CAPSULE IV, CHLORPHENIRAMINE MALEATE (OTC) COLD CAPSULE V, CHLORPHENIRAMINE MALEATE (OTC) COLESTID, COLESTIPOL HYDROCHLORIDE COLGATE TOTAL, SODIUM FLUORIDE...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt IN CLEON, FRANCE" 6362 04-Oct-84 SCHWARZ PHARMA LTD ISOSORBIDE 5-NITRATE DILUTED 6369 23-May-86 ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV OXYBUTYNIN CHLORIDE 6372 16-May-86 MDS NORDION "IODINE 131 MANUFACTURED IN KANATA, ONTARIO, CANADA." 6374 30-May-86 BACHEM FINE CHEMICALS INC "GROWTH HORMONE RELEASING FACTOR (GRF) (1-29) AMIDE, HUMAN" 6385 05-May-83 CENTRE PHARMACEUTIQUE...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls AMIODARONE HCL BAXTER ONCOLOGY GMBH IFOSFAMIDE GEDEON RICHTER LTD VINCRISTINE SULFATE FABBRICA ITALIANI SINTETICI SPA FUROSEMIDE DINAMITE DIPHARMA SPA TRIAMTERENE USP XIX/BP '73 DINAMITE DIPHARMA SPA CYPROHEPTADINE HCL, USP AVENTIS PHARMA SA PREDNISOLONE ACETATE NISSHIN FLOUR MILLING CO., LTDAMIODARONE HCL AS MANUF BY SEMPA-CHIMIE IN...
Prescription and Over-the-Counter Drug Product List: 3/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG;30MG N40441 001...
author: AUTHOR
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_JAN_1999.HTML 20-869 001 Merck Res 4-Jan-1999 LESCOL Fluvastatin Sodium Capsule 20-261 019 Novartis Pharm 4-Jan-1999 CORDARONE Amiodarone Hydrochloride Tablets 200 mg 18-972 017 Wyeth Ayerst Labs 5-Jan-1999 LAMISIL Terbinafine HCl Tablets 20-539 003 Novartis Pharms 5-Jan-1999 LOESTRIN FE 1.5/30 Ethinyl Estradiol/Norethindrone Tablets 17-355 043 Parke Davis 8-Jan-1999 LOESTRIN FE...
FDA Drug Approvals List July 2001 PERRIGO COMPANY Active Ingredient(s):ACETAMINOPHEN; ASPIRIN;CAFFEINE OTC/RX Status: RX Labeling Supplements to Original New Drug Applications Application #: 019906 Labeling Supplement#: 009 To Original New Drug Application Approval Date: 31-JUL-01 Trade Name: ANAFRANIL Dosage Form: CAPSULE Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): CLOMIPRAMINE HYDROCHLORIDE ...
Prescription and OTC Drug Product List 10/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 325MG;7.5MG N40464 001 OCT 23, 2002 OCT NEWA -A- AA 325MG;10MG N40464 002 OCT 23, 2002 OCT NEWA -A- AA 650MG;10MG N40476 001 OCT 23, 2002 OCT NEWA -A- AA 750MG;7.5MG N40469 001 OCT 25, 2002 OCT NEWA -A- AA MALLINCKRODT 750MG...
2003 Export Products List Alphabetical May also be effective in relieving the pain associated with various forms of arthritis, but is not indicated as primary therapy for rheuma ORDER # pms- PRODU TS FORMAT OMPARABLE TO LASSIFI ATION ( System): INDI ATIONS PRODU TS AVAILABLE FOR EXPORT Effe tive: July 2003 LISTINGS IN RED ARE C NTR LLED DRUGS pms- A etaminophen - pms- A etaminophen w/ odeine Page: 2 ORDER # pms- PRODU TS...
author: Lee S. Ehler
2003 Export Products List Alphabetical page 2
author: Lee S. Ehler
Microsoft Word - 75761.TA.doc ANDA 75- 761 August 23, 2001 American Pharmaceutical Partners, IncAmiodarone Hydrochloride Injection, 50...
author: staufferp
Microsoft Word - 75761.TA.doc page 1
author: staufferp
http://www.fda.gov/cder/foi/appletter/2001/75389ltr.pdf ANDA 75- 389 January 25, 2001 Barr Laboratories, IncAmiodarone Hydrochloride Tablets, 200 mg
http://www.fda.gov/cder/foi/appletter/2001/75389ltr.pdf page 1
http://www.fda.gov/cder/foi/appletter/2001/75424ltr.pdf page 1
FDA Drug Approvals List- January 1999 Drug Approvals for January 1999 Definitions and Notes January 1999 Original New Drug Applications Original Application #: 020781 Approval Date: 27-JAN-99 Trade Name: ZOFRAN ODT Chemical Type: Therapeutic Potential: Dosage Form: TABLET Applicant: GLAXO WELLCOME INC Active Ingredient(s): ONDANSETRON OTC/RX Status: RX Indication(s): For the prevention of chemotherapy and radiation...
FDA Drug Approvals List October 1999 Application #: 020156 Efficacy Supplement#: 022 Type: SE2 to Original New Drug Application Approval Date: 28-OCT-99 Trade Name: VIDEX Dosage Form: POWDER, FOR RECONSTITUTION Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): DIDANOSINE OTC/RX Status: RX Efficacy Claim:Provides for a new strength as well as allowing a change in dosing interval...
DDPA October 1995 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 18-482 PROCARDIA PFIZER LABS NIFEDIPINE 04-OCT-95 (CAPSULE) NEW YORK, NY 10MG 10017 20MG (LABELING REVISION -- DESCRIPTION; CLINICAL PHARMACOLOGY; WARNINGS; PRECAUTIONS; ADVERSE REACTIONS; OVERDOSAGE) 19-386 BREVIBLOC OHMEDA PHARM ESMOLOL HYDROCHLORIDE 04-OCT-95 (INJECTABLE) LIBERTY CORNER, NJ 10MG/ML 07938 250MG/ML (LABELING REVISION...
DDPA August 1995 DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER TRADE NAME APPLICANT ACTIVE INGREDIENT(S) APPROVAL DATE (DOSAGE FORM) STRENGTH(S) (CLASSIFICATION) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-377 CORDARONE WYETH AYERST AMIODARONE HYDROCHLORIDE 03-AUG-95 (INJECTABLE) PHILADELPHIA, PA 50MG/ML (3 S, V*) 19101...
DDPA April 1995 19-821 SORIATANE ROCHE ACITRETIN 03-APR-95 (CAPSULE) NUTLEY, NJ 10MG 07110 25MG (RETINOID) [TREATMENT OF SEVERE RECALCITRANT PSORIASIS] 20-325 PEPCID AC MERCK FAMOTIDINE 17-APR-95 (TABLET) WEST POINT, PA 10MG 19486 (HISTAMINE H2- RECEPTOR ANTAGONIST) [PREVENTION AND TREATMENT OF FOOD AND BEVERAGE INDUCED HEARTBURN, ACID INDIGESTION, AND SOUR STOMACH] (OTC) 20-059 ADENOSCAN MEDCO RES...
