News | News/Media | Cardinal Health Accordingly, the Company's actual results may differ materially from those expressed or implied in such forward-looking statements due to known and unknown risks and uncertainties that exist in the Company's operations and business environment, including, among other factors, the ability of the Company and each of its suppliers of doxercalciferol, Hectorol ® Injection...
DRAXIS Health Inc. Food and Drug Administration (FDA) has accepted DRAXIS Pharma as an additional manufacturing site for Bone Care’s Hectorol ® Injection (doxercalciferol) under a recently submitted CBE-30 supplemental application.Hectorol Injection, will encourage physicians to utilize Hectorol ...
DRAXIS Health Inc. Food and Drug Administration (FDA) has accepted DRAXIS Pharma as an additional manufacturing site for Bone Care’s Hectorol ® Injection (doxercalciferol) under a recently submitted CBE-30 supplemental application.Hectorol Injection, will encourage physicians to utilize Hectorol ...
Database D D - 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.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,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 4Q2003 TYPE2ACTIVETEXT DMF # SUBMIT DATE HOLDER SUBJECT 131 01-Jan-40 CENTRAL SOYA SOYBEAN STEROL PRODUCTS 183 29-Feb-52 INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 191 24-Jan-56 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE) 240 11-Jan-57 PHARMACIA & UPJOHN 19-NOR-ETHINYLTESTOSTERONE 281 21-Nov-57 UNIMED PHARMACEUTICALS INC 2 HYDROXY...
21027 Hectorol Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Hectorol (doxercalciferol) Injection Company:- Bone Care International Inc
author: Paul Stauffer
Pharmaceutical Research and Manufacturers of America - Bone Care International Complete a new search Drug Name (Proprietary name/Generic name) Indications Addressed Click on indication to see all drugs for that indication Company Click a company to see all drugs for that company Development Status Notes 1-alpha-hydroxy-vitamin D2 none / 1-alpha-hydroxy-vitamin D2 Prostate Cancer Bone Care International Middleton, WI Phase II - ...
Pharmaceutical Research and Manufacturers of America - Osteoporosis Complete a new search Drug Name (Proprietary name/Generic name) Indications Addressed Click on indication to see all drugs for that indication Company Click a company to see all drugs for that company Development Status Notes 3339 SERM none / 3339 SERM Osteoporosis Aventis Pharmaceuticals Bridgewater, NJ Phase II - bazedoxifene none / bazedoxifene Osteoporosis Ligand...
Pharmaceutical Research and Manufacturers of America - Chronic renal insufficiency Complete a new search Drug Name (Proprietary name/Generic name) Indications Addressed Click on indication to see all drugs for that indication Company Click a company to see all drugs for that company Development Status Notes Hectorol Hectorol / doxercalciferol Chronic renal insufficiency Hyperparathyroidism, Secondary Osteoporosis Bone...
C:\Documents and Settings\madarap\My Documents\Hectorol injection\S\ CM007 approval letter.doc DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 21- 027/ S- 007 Bone Care International Attention: Jill CHectorol &...
author: Patricia Madara
C:\Documents and Settings\madarap\My Documents\Hectorol injection\S\ CM007 approval letter.doc page 1
author: Patricia Madara
Reference Listed Drug Labeling Approved in June 2001 Jun 1 CEFAZOLIN AND DEXTROSE letter label cefazolin for injection/dextrose injection 50-779 S-001 Jun 5 LIMBITROL DS letter label chlordiazepoxide/amitriptyline HCl tablets 16-949 S-033 ZEMURON letter label rocuronium bromide injection 20-214 S-013 Jun 6 MENTAX letter label butenafine HCl cream 20-524 S-005 Jun 8 INTEGRILIN letter label eptifibatide injection 20-718 S-013 LIPITOR...
author: USERNAME
Report to the Nation: Drug Review Priority new drug approvals: Alitretinoin Amprenavir (2 dosage forms) Aspirin/extended release-dipyridamole Bexarotene Busulfan Caffeine citrate Cytarabine liposome Dalfopristin/quinupristin Epirubicin hydrochloride Ganirelix acetate Ketotifen fumarate Levonorgestrel Nedocromil sodium Nitric oxide Orlistat Oseltamivir phosphate Pemirolast potassium Pioglitazone hydrochloride...
author: OLIVERN
NMEs Approved in CY 1999 NMEs Approved in Calendar Year 1999 NDA Number Generic Name- Trade Name Dosage Form Applicant - --- Classification- Approval Date - - - - - - - 20-863 Cilostazol Pletal Tablet Otsuka Pharm 1S 01-15-1999 20-886 Alitretinoin Panretin Topical Gel Ligand Pharm 1-PV 02-02-1999 20-955 Sodium Ferric Gluconate Complex Ferrlicit Injectable R&D Labs 1P 02-18-1999 21-007 Amprenavir Agenerase...
author: Elaine Abraham
http://www.phrma.org/newmedicines/resources/2003-09-02.117.pdf Triangle Park, NC (daily oral regimen) (973) 235- 5000 Roche Nutley, NJ prevention and treatment of Phase III postmenopausal osteoporosis (888) 825- 5249 (monthly oral dosing) (973) 235- 5000 prevention and treatment of Phase III postmenopausal osteoporosis (888) 825- 5249 (quarterly IV dosing) (973) 235- 5000 Climara Pro ® Berlex Laboratories osteoporosis application submitted...
http://www.phrma.org/newmedicines/resources/2003-09-02.117.pdf page 22
http://www.phrma.org/newmedicines/resources/2003-09-02.117.pdf page 11
http://www.phrma.org/newmedicines/resources/2003-09-02.117.pdf page 3
FDA Drug Approvals List June 2001 PERRIGO COMPANY Active Ingredient(s): MONOXIDIL OTC/RX Status: RX Original Abbreviated Application # 075750 Approval Date: 8-JUN-01 Trade Name: DOXAZOSIN MESYLATE Dosage Form: TABLET Applicant: SIDMAK LABORATORIES, INC Active Ingredient(s): DOXAZOSIN MESYLATE OTC/RX Status: RX Original Abbreviated Application # 075502 Approval Date: 05-JUN-01 Trade Name: CLOTRIMAZOLE AND...
020862_Hectorol.htm Hectorol (Doxercalciferol) Capsules Food and Drug Administration • Center for Drug Evaluation and Research Approval Package [http://internet-dev/cder/templates/2ndrow-component.htm] [http://internet-dev/cder/templates/sidebar-component.htm] Hectorol (Doxercalciferol) Capsules Company:- Bone Care International Application No.:- 020-862 Approval Date:-6/9/99 - Approval Letter(s) & Final Printed Labeling ...
author: Paul Stauffer
FDA Drug Approvals List April 2000 - Drug Approvals for April 2000 Definitions and Notes Original New Drug Applications Original Application #: 021025 Approval Date: 21-APR-00 Trade Name: EXELON Chemical Type: 3 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): RIVASTIGMINE TARTRATE OTC/RX Status: RX Indication(s): For the treatment of mild to moderate...
Hectorol Consumer Information Hectorol ® Brand Name: Hectorol ® Active Ingredient: - doxercalciferol Strength(s): 2 mcg capsule; 4 mcg/ampule Dosage Form(s): - Capsules & Intravenous injection Company Name: -- Bone Care International Availability: ------- Prescription only *Date Approved by the FDA: - June 9, 1999 *Approval by FDA does not mean that the drug is available for consumers at...
Draxis Form 20-F for FYE 1201 as Filed SEDAR.DOC page 43
author: ChrisO
