Drug Approvals - B Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Bacitracin Injection, 50,000 units/vial, Rx American Pharmaceutical Partners ANDA 65-116 12/3/02 - - - Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, Rx Altana, Inc
http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
Bravelle 21484 Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Bravelle (urofollitropin) for injection Company:- Ferring Pharmaceuticals, Inc
author: USERNAME
../2002/21-289_Bravelle_ Food and Drug Administration • Center for Drug Evaluation and Research Title Search Bravelle (Urofollitropin) Injection Purified Company:--Femring Pharmaceuticals, Inc
author: USERNAME
Contents Vol. 17, No. 4, 2003 4, 2003 Contents Leading Article Protecting Innovation in Bioinformatics and In- Silico Biology 227- 231 R Harrison Drug Development Cationic Antimicrobial Peptides: Issues for Potential Clinical Use 233- 240 JP Bradshaw Quorum Sensing: A Novel Target for the Treatment of Biofilm 241- 250 Infections M Hentzer, L Eberl, J Nielsen, M Givskov Selective Replicating Viral Vectors:...
author: Adis International Limited
subject: BioDrugs
FDA Drug Approvals List May 2002 - Drug Approvals for May 2002 Definitions and Notes Original New Drug Applications Original Abbreviated Antibiotic Application # 065082 Approval Date: 31-MAY-02 Trade Name: CEFPODOXIME PROXETIL Dosage Form: GRANULE, FOR RECONSTITUTION Applicant: RANBAXY LABORATORIES LTD Active Ingredient(s): CEFPODOXIME PROXETIL OTC/RX Status: RX Original Application #: 021292 Approval Date: 31-MAY...
Prescription and OTC Drug Product List 5/2002 2 -D- + ROBINS AH 325MG;15MG N84444 001 MAY DISC -A- @ 325MG;15MG N84444 001 MAY DISC SOLUTION; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -D- AA ALPHARMA 120MG/5ML;12MG/5ML N85861 001 MAY CRLD -A- AA + 120MG/5ML;12MG/5ML N85861 001 MAY CRLD TYLENOL W/ CODEINE -D- AA + JOHNSON RW 120MG/5ML;12MG/5ML N85057 001 MAY DISC -A- @ 120MG/5ML;12MG/5ML N85057 001 MAY DISC TABLET; ORAL...
Document Information Page DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 21- 289 Ferrring Pharmaceuticals, IncBravelle (urofollitropin for...
author: FDA.CDER
Document Information Page page 1
author: FDA.CDER
C:\Data\My Documents\NDAs\n21484\approvlet.doc page 1
author: Archana Reddy
THE MERCK MANUAL, Sec. 18, Ch. 245, Infertility This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 18.
THE MERCK MANUAL, Sec. 18, Ch. 245, Infertility This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 18
Approved Biotechnology Drugs, 2002 Biotechnology Information, Advocacy and Business Support | About Us | BIO Events | BIO Members | Join BIO | Member Services | Links | Home CMS Payment System Prescription Coverage & Reimbursement Food & Agriculture Industrial & Environmental Bioethics & Biomedical Research Intellectual Property Regulatory Policies Tax & Fiscal Policies All Issues & Initiatives Press Releases Company...
Prescription and OTC Drug Product List 6/2002 -D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
BIO Editors &Reporters 03LIVE page 57
author: Elinor
RLD_LABELING_APPROVED_NOV_1999 Firm Date AMINOHIPPURATE Na Na Aminohippurate 5-619 S-015 Merck 2-Nov-1999 FLOLAN Epoprostenol Na Injection 20-444 S-004 Glaxo Wellcome 2-Nov-1999 DEXEDRINE Dextroamphetamine SO4 ER Capsules 17-078 S-034 SmithKline Beecham 3-Nov-1999 ZOLADEX Goserelin Acetate Implant 20-578 S-009 Zeneca 3-Nov-1999 ZOLADEX Goserelin Acetate Implant 3.6 Mg 19-726 S-030 Zeneca 3-Nov-1999 CERVIDIL...
_ BIO Citizen Petition (21 CFR § 10.30) Follow- on Therapeutic Proteins Biotechnology Industry Organization (BIO) 1225 Eye Street, NW, Suite 400 Washington, D
duplicates:http://www.bio.org/link.asp?url=%2Freg%2FBIO%5FCP%2D%2DFINAL%5FDRAFT%5F4%5F22%5F03%2Epdf
Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices Ioxaglate Sodium Iron Dextran Injection Iron Sorbitex Isobucaine HCI and Epinephrine Isoniazid Isoproterenol HCI Injection Isosuifan Sulfate Isoxsupine HCI Injection Kanamycin Sulfate Injection Ketamine HCI Labetalol HCI Leucovorin Calcium Injection Leuprolide Acetate Levallorphan Tartrate Injection Levarterenol Levorphanol Tartrate Injection Levothyroxine Sodium for Injection...
author: FDA / CBER
subject: December 1987 Guideline
Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices page 9
author: FDA / CBER
subject: December 1987 Guideline
http://www.adis.com/files/newsletters/INP/Icov1337.pdf ALLERGY Loratadine recommended for approval in the US 22 CANCER Alkylating agents associated with lung cancer 21 Antineoplastics in Burkitt's lymphoma/ leukaemia 18 Antineoplastics: regimens in Hodgkin's disease 16 Asparaginase vs pegaspargase in ALL 20 Docetaxel in androgen- independent prostate cancer 12 Estramustine phosphate sodium in prostate cancer 12 Fluorouracil- based...
http://www.adis.com/files/newsletters/INP/Icov1343.pdf aureus infections 13 PIs associated with sexual dysfunction in men 20 Treatments for paediatric HBV infection reviewed 4 MUSCULOSKELETAL S- 12911 in postmenopausal osteoporosis 12 Inhibition of COX- 2 impairs fracture healing 20 NEUROLOGY Antiepileptic drugs reviewed 3 News from the 54th AAN annual meeting 14 OBSTETRICS AND GYNAECOLOGY Antiretrovirals: low risk in pregnancy 21...
Drug Delivery A:link { text-decoration: none; color: blue } A:visited, A:active { text-decoration: none; color: blue } A:hover { color: blue; text-decoration: underline } Search Press Release TNO BIBRA Home News/Whats new ...
Hormone Bioassays A:link { text-decoration: none; color: blue } A:visited, A:active { text-decoration: none; color: blue } A:hover { color: blue; text-decoration: underline } Search Press Release TNO BIBRA Home News/Whats new ...
Prescription and OTC Drug Product List 11/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 11: November 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE AMOXICILLIN - ADD - TABLET; ORAL TABLET; ORAL - ADD - TRIZIVIR AMOXICILLIN - ADD - + GLAXO WELLCOME EQ 300MG BASE;150MG;300MG N21205 001 - ADD -...
PDPL - ADD - AB1 0.6MG/HR N89774 001 - DLT - SEARLE 0.35MG N17060 001 - ADD - AUG 30, 1996 - ADD - NOR-QD NITRO-DUR - ADD - + SEARLE 0.35MG N17060 001 - DLT - BX + KEY PHARMS 0.1MG/HR N20145 001 - DLT - APR 04, 1995 - DLT - BX + 0.2MG/HR N20145 002 NYSTATIN - DLT - APR 04, 1995 - DLT - BX + 0.4MG/HR N20145 004 POWDER; TOPICAL - DLT - APR 04, 1995 MYCOSTATIN - DLT - BX + 0.6MG/HR N20145...
