Drug Approvals - N Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Nabumetone Tablets, 500 mg, Rx- Second (Tentative Approval) Copley Pharmaceutical, IncNasonex (Mometasone Furoate Monohydrate) Aqueous Nasal Spray, Rx Schering CorpNasonex (...
http://www.fda.gov/cder/orange/appendix_a.txt 1/35 28, ETHINYL ESTRADIOL NABUMETONE, NABUMETONE NADOLOL, NADOLOL NAFAZAIR, NAPHAZOLINE HYDROCHLORIDE NAFCILLIN SODIUM, NAFCILLIN SODIUM NAFTIN, NAFTIFINE HYDROCHLORIDE NALBUPHINE HCL, NALBUPHINE HYDROCHLORIDE NALBUPHINE, NALBUPHINE HYDROCHLORIDE NALFON 200, FENOPROFEN CALCIUM NALFON, FENOPROFEN CALCIUM NALIDIXIC ACID, NALIDIXIC ACID APPENDIX A PRODUCT NAME INDEX NALLPEN IN PLASTIC...
FDA Drug Approvals List July 2002 - Drug Approvals for July 2002 Definitions and Notes Original New Drug Applications Original New Drug Application # 021409 Approval Date: 26-JUL-02 Trade Name: SINGULAIR Chemical Type: 3 Therapeutic Potential: S Dosage Form: GRANULE Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC Active Ingredient(s): MONTELUKAST SODIUM OTC/RX Status: RX Indication of Use: PROPHYLAXIS/CHRONIC...
Prescription and OTC Drug Product List October 1997 Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 10: Jan '97 - Oct '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE; ORAL OXYCODONE AND ACETAMINOPHEN TABLET;...
FDA Drug Approvals List December 1999 Original Application #: 020965 Approval Date: 03-DEC-99 Trade Name: LEVULAN KERASTICK Chemical Type: 1 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: ELINES, INCORPORATED Active Ingredient(s): AMINOLEVULINIC ACID HCL OTC/RX Status: RX Indication(s): For the use with a blue light irradiation using the BLU-U Illuminator for the photodynamic therapy of actinic keratoses of...
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE1 -SE7)* and EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE8)* - GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW- TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION ANASTROZOLE ASTRAZENECA 20-541 SE1 010 5-Mar-02 5-Sep-02 Y 6.0 Provides for the use of ARIMIDEX ...
author: Darlene Norris
Drug Approvals for October 1997 Drug Approvals for October 1997 Definitions and Notes October 1997 Original New Drug Applications Original Application #: 020755 Approval Date: 31-OCT-97 Trade Name: CAVERJECT Chemical Type: 5 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PHARMACIA AND UPJOHN CO Active Ingredient(s): ALPROSTADIL OTC/RX Status: RX Indication(s): Provides for an aqueous formulation for...
1998 Warning Letters and Untitled Letters to Pharmaceutical Companies DDMAC 6/25 6/29 Maxipime (Cefepime HCl) for Injection Bristol-Myers Squibb DDMAC 6/29 8/3 Mircette (Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol) Tablets Organon DDMAC 6/1 6/9 Naprelan (Naproxen Sodium) Tablets Wyeth-Ayerst DDMAC 6/8 6/29 Nasacort (Triamcinolone Acetonide) Rhone-Poulenc Rorer DDMAC 6/25 6/29 Nasonex (mometasone furoate monohydrate) nasal spray Schering...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt "PROPAFENONE HYDROCHLORIDE AS MFG IN PAULLO (MILANO), ITALY" 14987 25-Jul-00 SUN PHARMACEUTICAL INDUSTRIES LTD "PENTOXIFYLLINE E.P/B.P AS MFG IN MAHARASHTRA, INDIA" 14988 08-Aug-00 "NIPPON SODA CO., LTD." "FAROPENEM DALOXATE AS MFG IN TOYAMA, JAPAN" 14991 26-May-00 HOVIONE SOCIEDADE QUIMICA SA "MOMETASONE 17-FUROATE AS MFG IN LOURES, PORTUGAL" 14992 10-Aug-00 GLAXO...
FDA Drug Approvals List March 2002 - Drug Approvals for March 2002 Definitions and Notes Original New Drug Applications Original Application #: 020855 Approval Date: 21-MAR-02 Trade Name: MESNA Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: ASTA MEDICA AG Active Ingredient(s): MESNA OTC/RX Status: RX Indication(s): For the use as a prophylactic agent in reducing the incidence of ifosfamide...
SSCI Inc.: X-ray Powder Diffraction, Raman and Infrared Spectroscopy, Differential Scanning Calorimetry, and Thermogravimetric Phone: 800 375-2179 / 765 463-0112 Fax: 765 497-2649 / 765 463-4722 E-mail: info@ssci-inc.com SSCI Inc., 3065 Kent Avenue, West Lafayette, IN 47906 - 1076 USA Acetaminophen Acetazolamide Acetohexamide Acetylcysteine Acyclovir Adenine L-Alanine Albuterol Albuterol Sulfate Allopurinol Alprazolam Amantadine HCl Amiloride HCl Aminobenzoic Acid Aminoglutethimide Aminosalicylic Acid...
author: SSCI Webmaster
ranbaxy - - - - - - You are here :- Home - Products - - Dosage Forms - INDIA DOSAGE FORMS LIST- (Updated Jan 2002) Anti-infectives G.I. & Nutritionals CVS & Diabetes CNS NSAID & related Anti-allergants ...
http://www.fda.gov/cder/rdmt/escy99ap.htm EFFICACY SUPPLEMENTS APPROVED IN CY 99 GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPP TYPE SUPP NUMBER PRIOITY REVIEW TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION - - - - - - - - - - ATOVAQUONE GLAXO WELLCOME 20-500 03/06/98 01/05/99 SE1 5 N 10.0 Prevention of Pneumocystis carinii pneumonia (PCP)
author: Darlene
DDPA November 1995 74-493 CAPTOPRIL PAR CAPTOPRIL 14-NOV-95 (TABLET) SPRING VALLEY, NY 12.5MG 10977 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 19-543 ELOCON SCHERING MOMETASONE FUROATE 03-OCT-95 (OINTMENT) KENILWORTH, NJ 0.1% 07033 (LABELING REVISION -- INDICATIONS AND USAGE; PRECAUTIONS; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION...
Perrigo | Newsroom | Press Releases document.write(' ') Recent News Releases For additional media information contact: Ernie Schenk eschenk@perrigo.com 269-673-9212 (direct) 269-673-9128 (fax) Perrigo Company Announces Dividend Increase Oct 28, 2005 Board declares quarterly dividend of $0.0425 per share.
Ligand: Research & Development: Clinical Trials: Targretin® gel Scientific Publications Clinical Trials Clinical Trial Results AVINZA® capsules Targretin® capsules Targretin® gel PK Studies Product Pipeline Home » Research & Development » Clinical Trials Results » Targretin® gel Clinical Trials Results - Targretin® gel Clinical Target Trial ID Trial Title Trial Phase Trial Dates* M/D/Y Citation to Results...
author: PINT [ www.pint.com ]
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 10/31/03 11/5...
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...
Patent and Exclusivity Terms U-239 TREATING OR CONTROLLING OCULAR INFLAMMATION WHICH COMPRISES TOPICALLY ADMINISTERING TO THE AFFECTED EYE A COMPOSITION COMPRISING AN NSAID, A POLYMERIC QUATERNARY AMMONIUM COMPOUND AND BORIC ACID U-240 TREATMENT OF ACUTE MIGRAINE ATTACKS U-241 FOR SHORT-TERM TREATMENT ACTIVE DUODENAL ULCER, MAINTENANCE THERAPY FOR DUODENAL ULCER PATIENTS AT REDUCED DOSAGE AFTER HEALING OF ACTIVE...
Prescription and Over-the-Counter Drug Product List: 11/2003 ACTHAR GEL >D> BC + QUESTCOR PHARMS 80 UNITS/ML N08372 008 NOV CTEC >A> + 80 UNITS/ML N08372 008 NOV CTEC CYTARABINE INJECTABLE; INJECTION >D> CYTARABINE >D> AP + GENSIA SICOR PHARMS 100MG/VIAL N16793 001 NOV DISC >D> AP + 500MG/VIAL N16793 002 NOV DISC >D> AP + 1GM/VIAL N16793 003 DEC 21, 1987 NOV DISC >D> AP + 2GM/VIAL N16793 004 DEC 21, 1987 NOV DISC >A> @ SICOR PHARMS 100MG/VIAL...
Welcome to Pharmaceutical Profiles Inhaled Drug Delivery Bibliography The following are a selection of key papers from the Pharmaceutical Profiles' bibliography for inhaled drug delivery research
ANDA Approvals: March, 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - March 2002 - ANDA Number Drug Name Applicant Approval Date 1 75-385 BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG, AND 15 MG ZENITH GOLDLINE PHARMACEUTICALS, INC
author: AmesT
ANDA Tentative Approvals - February 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - February 2002 - ANDA Number Drug Name Applicant Tentative Approval Date 1 76-067 MOMETASONE FUROATE OINTMENT, USP 0.1% CLAY-PARK LABS, INC
author: USERNAME
First Time Generics - March 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - March 2002 - Generic Name- Generic Manufacturer Brand Name--- Approval Date 1- AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 875 MG AND 125 MG (BASE), RESPECTIVELY GENEVA PHARMACEUTICALS, INC
author: AmesT
CDER Template - Replace Title Here Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - July 2002 - ANDA Number Drug Name Applicant Tentative Approval- Date 1 75-706 LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABLETS-------- 10 MG/240 MG (24-HOUR FORMULATION) ANDRX PHARMACEUTICALS, LLC 7/9/02 2 75-919 MOMETASONE FUROATE ...
author: USERNAME
