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,...
PRESCRIPTION DRUG PRODUCT LIST 17TH EDITION RX DRUG PRODUCT LIST Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 3: Feb '97 - Mar '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - - ADD - AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; - ADD - AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; - ADD - POTASSIUM PHOSPHATE, DIBASIC; SODIUM...
FDA Drug Approvals List Drug Approvals for March 1997 Definitions and Notes March 1997 Original New Drug Applications Original Application #: 020570 Approval Date: 28-MAR-97 Trade Name: QUADRAMET Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: CYTOGEN CORP Active Ingredient(s): SAMARIUM SM 153 EDTMP OTC/RX Status: RX Indication(s): For relief of pain in patients with confirmed...
Drug Approvals January 1997 Drug Approvals for January 1997 Definitions and Notes January 1997 Original New Drug Applications Original Application #: 050733 Approval Date: 30-JAN-97 Trade Name: ZITHROMAX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PFIZER INC Active Ingredient(s): AZITHROMYCIN OTC/RX Status: RX Indication(s): Treatment of patients with community-acquired...
FDA Drug Approvals List March 2000 Original Application #: 021124 Approval Date: 17-MAR-00 Trade Name: LAMISIL Chemical Type: 6 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: NOVARTIS PHARMACEUTICALS CORP DBA SANDOZ PHARMACEUTICALS CORP Active Ingredient(s): TERBINAFINE HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the treatment of interdigital-type pedis (athlete’s foot), tinea cruris (jock...
Reference Listed Drug Labeling Approved in March 2000 TRADENAME ACTIVE/DOSAGE FORM NDA# SUPP# FIRM MAR DIOVAN HCT Valsartan/HCTZ/tab 20-818 S-006 Novartis Pharms 1 TIMOPTIC in OCCUDOSE Timolol maleate/opth.sol 19-463 S-020 Merck 2 EFFEXOR Venlafaxine HCl 20-151 S-014 Wyeth Ayerst 3 EFFEXOR XR Venlafaxine HCl 20-699 S-008 Wyeth Ayerst 3 TECZEM Diltiazem malate/enalapril maleate 20-507 S-002 Aventis Pharms 3 PROPULSID Cisapride/oral sol...
author: USERNAME
Shire Pharmaceuticals plc - Biotech Analytics Click above for profile 30th December 2002 – Shire Pharmaceuticals Plc – sale of Over The Counter Products Portfolio to Purdue Shire Pharmaceuticals Group plc announces that it has sold its US Over The ...
Current UK Biotechnology Company News Summary--------------- Previous News Summary Page Previous News Summary Page This page is updated whenever there is a UK biotechnology company press release. Follow the individual hyperlinks for more detailed company news. 30th April 2001 - Cambridge ...
20333S02.PDF Agrylin was effective in phlebotomized patients as well as in patients treated with other concomitant therapies including hydroxyurea, aspirin, interferon, radioactive phosphorus, and alkylating agentsAnagrelide therapy requires close clinical supervision of the patientAnagrelide hydrochloride was NDA 20- 333/ S- 002 Page 9 not...
author: Unknown
20333S02.PDF page 4
author: Unknown
Drug Approvals - A NDA 20-884/S-003 - 5/1/01 - - Agrylin (anagrelide hydrochloride) Capsules(not a new route of administration), Rx Roberts Laboratories, IncAgrylin Indication: Agrylin Capsules are indicated for the treatment of patients with Essential Thrombocythemia to reduce the elevated platelet count and the risk of thrombosis...
http://www.fda.gov/cder/dmf/text/4Q2003NEWTEXT.txt CHINA." 16892 V 3-Sep-2003 ALTHEA TECHNOLOGIES INC "ASEPTIC FORMULATION, FILL, AND FINISH FACILITY IN SAN DIEGO, CA." 16893 III 15-Sep-2003 ERIE MOLDED PLASTICS INC "LID FOR DEODORANT AS MANUFACTURED IN ERIE, PA." 16894 II 5-Oct-2003 DIVIS LABORATORIES LTD "LEVITERACETAM AS MANUFACTURED IN ANDHRA PRADESH, INDIA." 16895 IV 6-Oct-2003 FIRMENICH INC "NATURAL & ARTIFICIAL ORANGE FLAVOR...
http://www.fda.gov/cder/dmf/xls/4Q2003NEWEXCEL.xls II RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA SERTRALINE HYDROCHLORIDE FORM II AS MANUFACTURED IN CAMPOVERDE DI APRILIA (LT), ITALYHYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA II NICHOLAS PIRAMAL INDIA LTD ITRACONAZOLE AS MANUFACTURED IN ANDHRA...
Efficacy Supplements Approved in Calendar Year 1998 ANAGRELIDE HYDROCHLORIDE ROBERTS LABS 20-333 02-Jan-98 16-Dec-98 SE1 11.4 Treatment of patients with thrombocythemia, secondary to myeloproliferative disorders, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic eventsHYDROCHLORIDE BIOVAIL LABS 20-401 30-Jan-97 30-Jan-98...
author: Brenda Harmon
COMP Press Release 9th meeting Press Release The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 13 E- mail: mail@ emea. eudra. org http:// www. eudra. org/ emea. html 18 January 2001 COMP/ 16/ 01 corr. ...
author: COMP
subject: Press Release
COMP Press Release 9th meeting page 3 Press Release COMP/ 16/ 01 3/ 6 ANNEX I to COMP January 2001 Press Release Medicinal products Designated as Orphan Medicinal Products since the December 2000 Press Release Active substance Thalidomide Sponsor Laboratoires Laphal Orphan Indication Treatment of Erythema nodosum leprosum (ENL) or type II lepra ...
author: COMP
subject: Press Release
