http://www.fda.gov/cder/orange/appendix_a.txt PEDIATRIC, ASCORBIC ACID M.V.I.-12 LYOPHILIZED, ASCORBIC ACID M.V.I.-12, ASCORBIC ACID MACROBID, NITROFURANTOIN MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE MACROTEC, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT MAGNACORT, HYDROCORTAMATE HYDROCHLORIDE MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE MAGNESIUM SULFATE IN PLASTIC CONTAINER,...
FDA Drug Approvals List Active Ingredient(s): NEDOCROMIL SODIUM OTC/RX Status: RX Efficacy Claim: Extending the approved use to the pediatric population of 6-11 years of age Approvable Original New Drug Applications Original Application #: 019781 Approvable Date: 31-MAR-97 Trade Name: PROMETRIUM Dosage Form: CAPSULE Applicant: SCHERING PLOUGH CORP Active Ingredient(s): PROGESTERONE OTC/RX Status: RX...
FDA Drug Approvals List- February 1998 Drug Approvals for February 1998 Definitions and Notes February 1998 Original New Drug Applications Original Application #: 050750 Approval Date: 24-FEB-98 Trade Name: ZOSYN Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: LEDERLE PIPERACILLIN INC DIV AMERICAN CYANAMID CO Active Ingredient(s): PIPERACILLIN SODIUM; TAZOBACTAM SODIUM OTC/RX Status: RX...
DDPA February 1996 THERE ARE NO ORIGINAL ABBREVIATED AND 505(b)(2) NDAs WITH TENTATIVE APPROVALS FOR FEBRUARY 1996 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 20-123 OMNIS CAN NYCOMED GADODIAMIDE 05-FEB-96 (INJECTABLE) WAYNE, PA 287MG/ML 19087 (LABELING REVISION -- INDICATIONS AND USAGE; DOSAGE AND ADMINISTRATION) 19-099 DOPAMINE HCL AND MCGAW DOPAMINE HYDROCHLORIDE 07-FEB-96 DEXTROSE 5% IRVINE, CA...
Drug Approvals for July 1997 Drug Approvals for July 1997 Definitions and Notes July 1997 Original New Drug Applications Original Application #: 020701 Approval Date: 31-JUL-97 Trade Name: CRINONE Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: COLUMBIA RESEARCH LABORATORIES INC Active Ingredient(s): PROGESTERONE OTC/RX Status: RX Indication(s): Treatment of secondary amenorrhea Original...
DDPA January 1995 50-703 BACTROBAN SMITHKLINE BEECHAM MUP IROCIN CALCIUM 20-JAN-95 (OINTMENT) KING OF PRUSSIA, PA EQ 2% BASE 19406 (ANTIBACTERIAL) 50-710 ZITHROMAX PFIZER AZITHROMYCIN DIHYDRATE 27-JAN-95 (POWDER, GROTON, CT EQ 100MG BASE/5ML FOR RECONSTITUTION) 06340 EQ 200MG BASE/5ML EQ 1GM/PACKET (ANTIBIOTIC, MACROLIDE) ***ORIGINAL ABBREVIATED NDAs*** 73-580* MEBENDAZOLE COPLEY PHARM MEBENDAZOLE 04...
http://www.fda.gov/cder/da/ddpa93.wpd 20 198 NIFEDIPINE MILES NIFEDIPINE 01 29 93 (TABLET, WEST HAVEN, CT 30MG EXTENDED RELEASE) 06516 60MG 90MG (CALCIUM ION INFLUX INHIBITOR) 20 288 MONISTAT 7 ADVANCED CARE MICONAZOLE NITRATE 01 29 93 COMBINATION PACK RARITAN, NJ 100MG-SUPPOSITORY (SUPPOSITORY/CREAM) 08869 2%-CREAM (ANTIFUNGAL) 20 289 GYNE LOTRIMIN SCHERING CLOTRIMAZOLE 01 29 93 COMBINATION PACK LIBERTY CORNER, NJ 100MG...
UCB Galapagos Genomics and Procter & Gamble Pharmaceuticals Announce Functional Genomics Collaboration Mechelen, Belgium, and Cincinnati, OH, USA, 22 October, 2001.
author: BETHEUNL
UCB page 2
author: BETHEUNL
Galapagos NV Galapagos Genomics and Procter & Gamble Pharmaceuticals Announce Functional Genomics Collaboration Mechelen, Belgium, and Cincinnati, OH, USA, 22 October, 2001.
UCB Galapagos Genomics and Procter & Gamble Extend Target Validation Collaboration Mechelen, Belgium, September 3, 2002.
author: BETHEUNL
UCB page 2
author: BETHEUNL
Galapagos NV Galapagos Genomics and Procter & Gamble Extend Target Validation Collaboration Mechelen, Belgium, September 3, 2002.
Galapagos launches gene silencing platform Galapagos Genomics and Procter & Gamble Collaborate in Osteoporosis Mechelen, Belgium, June 11, 2003 Galapagos Genomics, a privately held functional genomics company, today announced that it has entered into collaboration with Procter & Gamble in the field of osteoporosis.
author: Onno van de Stolpe
Galapagos launches gene silencing platform page 2
author: Onno van de Stolpe
Galapagos NV Galapagos Genomics and Procter & Gamble Collaborate in Osteoporosis Mechelen, Belgium, June 11, 2003 -- Galapagos Genomics, a privately held functional genomics company, today announced that it has entered into collaboration with Procter & Gamble in the field of osteoporosis.
Urinary Tract Infections in Teens and Adults - Quest Diagnostics Patient Health Library Urinary Tract Infections in Teens and Adults Medications Oral antibiotics can treat most bladder infections and uncomplicated kidney infections successfully.
Bicarbonate - [Medical Test] - Quest Diagnostics Patient Health Library Bicarbonate Results A bicarbonate (HCO3) test measures the blood level of the buffer bicarbonate, which prevents the buildup of acid in the blood.
Arterial Blood Gases - [Medical Test] - Quest Diagnostics Patient Health Library Arterial Blood Gases Results An arterial blood gas (ABG) test can measure the levels of oxygen and carbon dioxide in the blood to determine how well the lungs are working.
Antibiotics for urinary tract infections in children - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Antibiotics for urinary tract infections in children - [Medication] - Quest Diagnostics Patient Health Library Antibiotics for urinary tract infections in children - [Medication] - Quest Diagnostics Patient Health Library Children’s health, Infant and...
Nitrofurantoin for urinary tract infections (UTIs) - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About Nitrofurantoin for urinary tract infections (UTIs) - [Medication] - Quest Diagnostics Patient Health Library Nitrofurantoin for urinary tract infections (UTIs) - [Medication] - Quest Diagnostics Patient Health Library Urinary system, Antibiotic, Antibiotics,...
Drug Approvals - M Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted M-Zole 3 Combination Pack [Miconazole Nitrate Vaginal Suppositories USP, 200 mg and Miconazole Cream USP, 2% (Combination package)], OTC, Alpharma ANDA 74-926 4/16/99 4/28/99 - 1/14/02 Macrobid (nitrofurantoin monohydrate/macrocrystals) Capsules,- Procter & Gamble NDA 20-064/S-014 10...
Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
1997 Warning Letters and Notice of Violation Letters to Pharmaceutical Companies Johnson DDMAC 9/24/1997 5/29/1998 Posicor (Mibefradil Dihyrdrochloride) Tablets Hoffman-La Roche DDMAC 9/5/1997 5/29/1998 Salagen (Pilo carpine HCl) MGI Pharma DDMAC 9/24/1997 5/29/1998 Site Inspection Gedeon Richter, Ltd DMPQ 9/5/1997 9/24/1997 Zocor (Simvastatin) Merck DDMAC 9/22/1997 5/29/1998 October 1997 Accolate (Zafirkulast) Tablets Zeneca Pharmaceuticals DDMAC 10/1/1997 5/22...
Phase Forward - Press Releases Products Services Support Alliances News & Events Customers About Us Contact Us Home Press Releases PHASE FORWARD ANNOUNCES AGREEMENT WITH PROCTER & GAMBLE PHARMACEUTICALS --Procter & Gamble to Deploy Phase Forward's InForm™ Software for Web-Based Clinical Trial Management -- WALTHAM, MA - June 12, 2001 - Phase Forward, the pioneer in proven e-process solutions for accelerating...
