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...
http://www.fda.gov/cder/orange/appendix_a.txt ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt CHINA" 13150 21-Aug-98 POLYPEPTIDE LABS INC "LEUPROLIDE, MANUFACTURED IN TORRANCE, CA" 13151 24-Aug-98 VALEANT PHARMACEUTICALS INTERNATIONAL "MOGADON (NITRAZEPAM) TABLETS, MANUFACTURED IN BASEL, SWITZERLAND" 13152 25-Aug-98 ISO TEX DIAGNOSTICS INC "INDIUM-111, MANUFACTURED IN FRIENDSWOOD, TEXAS" 13155 26-Aug-98 REPLIGEN CORP "IMMOBILIZED (R) PROTEIN A (TM,) IPA-500, MANUFACTURED IN...
ANDAs Approvals - May 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals May 2000 - 1HYDROCHLORIDE GENPHARM INCHYDROCHLORIDE EON LABS MANUFACTURING, 5/1/00 TABLETS 80 MG 120 MG 160 MG INCHYDROCHLORIDE ...
author: USERNAME
ANDAs Approvals - July 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals - July 2000 1HYDROCHLORIDE WATSON LABORATORIES, INC
author: USERNAME
ANDA Approvals - August 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - August 2002 - ANDA Number Generic Drug Name Applicant Approval Date 1 40-452 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 MG/30 MG ABLE LABORATORIES, INCHYDROCHLORIDE AND ACETAMINOPHEN TABLETS 25 MG (BASE)/650 MG AMIDE...
author: OGD
74-315_Terazosin Hydrochloride Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Terazosin Hydrochloride Tablets Company:--Geneva Pharmaceuticals, Inc
author: Paul Stauffer
75140_Terazosin.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Terazosin Hydrochloride Capsules Company:--Mylan Pharmaceuticals Inc
author: Paul Stauffer
1997 Abbreviated New Drug Applications (Generic Drugs) 074946 11/19/1997 3/30/1998 Adriamycin PFS (Doxorubicin Hydrochloride) Injection ,- Adria Laboratories 63165/S3, S5, S6 7/9/1993 8/8/2002 Albuterol Inhalation Aerolsol, 90 mcg/ActuationHydrochloride [2 MB] Taro Pharmaceuticals 074694 12/13/1996 12/3/1997 Clomipramine Hydrochloride Capsules, 25, 50, & 75 mg
ANDA Approvals April 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Approvals April 2001 - ANDA Number Drug Name Applicant Approval Date 1 75-547 THIOTEPA FOR INJECTION, USP 15 MG/VIAL BEDFORD LABORATORIES 4/2/01 2 75-498 TERAZOSIN HYDROCHLORIDE CAPSULES 1 MG (BASE) 2 MG (BASE) 5 MG (BASE) 10 MG (BASE) TORPHARM 4/12/01 3 75-630 BETAXOLOL...
author: USERNAME
FDA Drug Approvals List April 2001 - Drug Approvals for April 2001 Definitions and Notes Original New Drug Applications Original Application #: 020949 Approval Date: 30-APR-01 Trade Name: ACCUNEB Chemical Type: 5 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: DEY LABORATORIES INC Active Ingredient(s): ALBUTEROL SULFATE OTC/RX Status: RX Indication(s): For the treatment of asthma-related bronchospasm in...
Prescription and OTC Drug Product List 8/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -A- AA ABLE 300MG;30MG N40452 001 AUG 01, 2002 AUG NEWA -A- AA 300MG;60MG N40459 001 AUG 01, 2002 AUG NEWA ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE TABLET; ORAL ACETAMINOPHEN AND PENTAZOCINE HCL -A- AB AMIDE PHARM 650MG;EQ 25MG BASE N76202 001...
FDA Drug Approvals List April 2000 Approvable Original New Drug Applications Original Abbreviated New Drug Applications Original Abbreviated Application # 074657 Approval Date: 28-APR-00 Trade Name: TERAZOSIN HCL Dosage Form: TABLET Applicant: INVAMED INC Active Ingredient(s): TERAZOSIN HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application# 065041 Approval Date: 28-APR-00 Trade...
FDA Drug Approvals List February 2000 - Drug Approvals for February 2000 Definitions and Notes Original New Drug Applications Original Application #: 021015 Approval Date: 28-FEB-00 Trade Name: ANDROGEL Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: UNIMED PHARMACEUTICALS INC Active Ingredient(s): TESTOSTERONE OTC/RX Status: RX Indication(s): For replacement therapy in males for conditions...
Microsoft PowerPoint - FTC - Markus Meier [Read-Only] THE FTC's PHARMACEUTICAL CASES Markus HTerazosin Hydrochloride Antitrust Litig., 164 F
author: Pamela Putz
Microsoft PowerPoint - FTC - Markus Meier [Read-Only] page 20
author: Pamela Putz
ranbaxy - - - - -- - You are here :- Home - News Room - October 2002 RANBAXY'S Q3 NET PROFIT (PAT) UP BY 79% US SALES SURPASS US$ 200 MN: JANUARY – SEPTEMBER 2002 October 16, 2002, New Jersey, USA The Board of ...
ranbaxy - -- - - - You are here :- Home - News Room - - Press Releases Press Releases - Choose Year : -- Press Releases for the year 2002 December 2002 DaY : 10 RANBAXY TO LAUNCH GENERIC CO-AMOXYCLAV IN THE US MARKET ...
ranbaxy - - - - -- You are here :- Home - News Room - August 2002 RANBAXY GAINS US FDA APPROVAL TO MARKET TERAZOSIN HYDROCHLORIDE CAPSULES New Delhi, August 26, 2002 Ranbaxy Pharmaceuticals Inc., (RPI), a wholly ...
ranbaxy - - - - -- - You are here :- Home - News Room - August 2002 RANBAXY GAINS US FDA APPROVAL TO MARKET TERAZOSIN HYDROCHLORIDE CAPSULES New Delhi, August 26, 2002 Ranbaxy Pharmaceuticals Inc., (RPI), a wholly ...
ranbaxy - - - - -- You are here :- Home - News Room - October 2002 RANBAXY'S Q3 NET PROFIT (PAT) UP BY 79% US SALES SURPASS US$ 200 MN: JANUARY – SEPTEMBER 2002 October 16, 2002, New Jersey, USA The Board of ...
ranbaxy - -- - - - - You are here :- Home - News Room - - Press Releases Press Releases July 2001 RANBAXY`S ANTI-AIDS DRUG -LAMIVUDINE- GETS APPROVAL RANBAXY QUARTER TWO SALES UP BY 18%,PAT BY 22% RANBAXY'S Q2 NET ...
ranbaxy - -- - - - - You are here :- Home - News Room - - Press Releases Press Releases July 2002 RANBAXY'S Q2 NET PROFIT (PAT) UP BY 190%; OVERSEAS BUSINESS CONSTITUTES 70% OF GLOBAL SALES; DECLARES 3 FOR 5 BONUS ...
Selected Publications (First Author) RYOICHI NAGATA, M.D., Ph.D
ranbaxy - - - - - - You are here :- Home - Investor Relations - Latest Financial Results RANBAXY'S Q3 NET PROFIT (PAT) UP BY 79% US SALES SURPASS US$ 200 MN: JANUARY – SEPTEMBER 2002 October 16, 2002, New ...
