http://www.fda.gov/cder/orange/appendix_a.txt RTU IN PLASTIC CONTAINER, METRONIDAZOLE FLAGYL I.V., METRONIDAZOLE HYDROCHLORIDE FLAGYL, METRONIDAZOLE FLAREX, FLUOROMETHOLONE ACETATE FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE FLAVOXATE HCL, FLAVOXATE HYDROCHLORIDE FLAXEDIL, GALLAMINE TRIETHIODIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE FLEXICORT, HYDROCORTISONE FLOLAN,...
Prescription and Over-the-Counter Drug Product List: 6/2003 >D> AP + WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUN DISC >A> @ 5,000 UNITS/VIAL N17055 001 JUN DISC >D> AP + 10,000 UNITS/VIAL N17055 002 JUN DISC >A> @ 10,000 UNITS/VIAL N17055 002 JUN DISC GUANABENZ ACETATE TABLET; ORAL GUANABENZ ACETATE >D> AB WATSON LABS EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >A> AB + EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >D> WYTENSIN ...
author: AUTHOR
FDA Drug Approvals List October 2001 Active Ingredient(s): OXAPROZIN OTC/RX Status: RX Original Abbreviated Application # 075839 Approval Date: 1-OCT-01 Trade Name: MINOXIDIL Dosage Form: SOLUTION Applicant: NOVEX PHARMA Active Ingredient(s): MINOXIDIL OTC/RX Status: RX Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval Original Abbreviated Application #: 075834 Tentative Approval Date: 30...
Drug Approvals for September 1997 The development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program Original Application #: 020857 Approval Date: 26-SEP-97 Trade Name: COMBIVIR Chemical Type: 4 Therapeutic Potential: P Dosage Form: TABLET Applicant: GLAXO WELLCOME INC Active Ingredient(s): LAMIVUDINE; ZIDOVUDINE OTC/RX Status: RX Indication(s): Treatment...
Approved Products_2004.xls Number A pproval Date Trade Name Generic/ Chemical name Indication Company 1 Oct- 82 Humulin Human Insulin Type I Diabetes Lilly / Genentech 2 Oct- 85 Protro pin Human Growth Hormone Hypoptuitary dwarfism Genentech 3 Jun- 86 Intron A Interferon Al pha 2B Hairy Cell Leukemia Schering Plough / Biogen 4 Jun- 86 OKT- 3 Anti CD3 Mab Acute Trans plant Rejection JNJ / OrthoBiotech 5 Jun- 86...
author: Reijer
Approved Products_2004.xls page 2
author: Reijer
Drug Shortages FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - - Drug Shortages - Introduction FAQs Current Drug Shortages - Resolved Drug Shortages Drugs to be Discontinued - Drug Shortage Manual of Policies and Procedures (MaPP) Medical Necessity Guidance Document How to Report a Drug Shortage - Practical Steps for Practitioners Facing Shortage...
Reference Listed Drug Labeling Approved in October 2001 Food and Drug Administration • Center for Drug Evaluation and Research Office of Generic Drugs Search Reference Listed Drug Labeling Supplements Approved in October 2001 Click on appropriate hyperlink below to view available source document in PDF format
author: USERNAME
http://www.microbix.com/PDFs/3487_Generic%20Biologics_rpt.pdf page 5
C:\My Documents\labelingsupps\GEREFS06ap.DOC DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 NDA 19- 863/ S- 006 Serono Laboratories, Inc Attention: Bob Kirsch Director, Regulatory Affairs 100 Longwater Circle Norwell, MA 02061 Dear Mr
author: Kati Johnson
C:\My Documents\labelingsupps\GEREFS06ap.DOC page 1
author: Kati Johnson
http://www.freseniushc.com/product/April_1_2001_Update.pdf April 1 2001 Update Addendum A. Update of Calendar Year 2001 Hospital Outpatient Payment Rates and Coinsurance Amounts Effective April 1, 2001 National Minimum Status Relative Payment Unadjusted Unadjusted APC Group Title Indicator Weight Rate Coinsurance Coinsurance 0001 Photochemotherapy ...
