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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...
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http://www.fda.gov/cder/orange/appendix_a.txt
400, ERYTHROMYCIN ETHYLSUCCINATE E.E.S., ERYTHROMYCIN ETHYLSUCCINATE EC-NAPROSYN, NAPROXEN ECONAZOLE NITRATE, ECONAZOLE NITRATE ECONOCHLOR, CHLORAMPHENICOL ECONOPRED PLUS, PREDNISOLONE ACETATE ECONOPRED, PREDNISOLONE ACETATE EDECRIN, ETHACRYNATE SODIUM EDECRIN, ETHACRYNIC ACID EDETATE DISODIUM, EDETATE DISODIUM EDEX, ALPROSTADIL EDROPHONIUM CHLORIDE PRESERVATIVE FREE, EDROPHONIUM...
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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
AUGMENTIN TABLETS, 875 MG 3/14/02 2- MIDAZOLAM HYDROCHLORIDE...
author: AmesT
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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...
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Prescription and OTC Drug Product List 3/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ALBUTEROL SULFATE AEROSOL, METERED; INHALATION PROVENTIL-HFA -D- + 3M EQ 0.09MG BASE/INH N20503 001 AUG 15, 1996 MAR CTEC -A- BX + EQ 0.09MG BASE/INH N20503 001 AUG 15, 1996 MAR CTEC VENTOLIN HFA -D- + GLAXOSMITHKLINE EQ 0.09MG BASE/INH N20983 001 APR 19, 2001 MAR CTEC -A- BX + EQ 0.09MG BASE/INH N20983 001 APR 19, 2001 MAR CTEC...
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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...
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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.
See Attachment Perrigo Company Announces Tentative Approval For Famotidine Tablets Sep 12, 2005 Tentative...
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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 ]
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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...
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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, Inc
ANDA 75-416 3/17/00 3/21/00 - - Naproxen Sodium Tablets, 275 & 550 mg, Rx Able Laboratories ANDA 76-544 8/22/03 - Naproxen Sodium Tablets, 220 mg (200 mg base), OTC Par Pharmaceutical ANDA 75-168 7/28/98 7...
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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...
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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...
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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...
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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
Journal of Pharmaceutics 245 (2002) 123-132
No 3
2 pp 139-145
Journal of Aerosol Medicine Vol 13 No
Pickering H, Pitcairn G R, Hirst P H, Bacon R E, Newman SP, Affrime MB, Marino M (2000) Regional Lung...
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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
3/1/02 2 75-610 FAMOTIDINE TABLETS, USP (OTC) 10 MG TORPHARM 3/12/02 3 75-824 BUTORPHANOL TARTRATE NASAL...
author: AmesT
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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
2/1/02 2 75-928 CIPROFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% NOVEX PHARMA 2/4/02 3 76-059 LISINOPRIL TABLETS,...
author: USERNAME
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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
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Efficacy Supplements Approved in Calendar Year 1998
EFFICACY SUPPLEMENTS APPROVED IN CY 98 GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPPLEMENT TYPE TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION ACARBOSE BAYER 20-482 30-Sep-97 29-Sep-98 SE1 12.0 For patients with type 2 diabetes treated with diet plus insulin
CISATRACURIUM BESYLATE GLAXO WELLCOME 20-551 24-Oct-97 15-Oct-98 SE8 11.7 Adjunct to general...
author: Brenda Harmon
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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...
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FDA Drug Approvals List February 2002
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application#065022 Approval Date: 27-FEB-02 Trade Name: BACITRACIN ZINC AND POLYMYXIN B SULFATE Dosage Form: OINTMENT Applicant: ALTANA INC Active Ingredient(s): BACITRACIN ZINC; POLYMYXIN B SULFATE OTC/RX Status: RX Original Abbreviated Application# 075874 Approval Date: 26-FEB-02 Trade...
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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
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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
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01-287 PhRMA NewMed WomenforPDF page 16
author: RL
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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 ...
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Contents Vol. 61, No. 9, 2001
1231- 1238 AE Redington Leading Article Matrix Metalloproteinases in the Progression of Heart Failure: Potential Therapeutic Implications 1239- 1252 YY Li, AM Feldman Review Article The Clinical and Cost Considerations of Bisphosphonates in Preventing Bone Complications in Patients with Metastatic Breast Cancer or Multiple Myeloma 1253- 1274 EV McCloskey, JF Guest, JA Kanis Therapy...
author: Adis International Limited
subject: Drugs
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