http://www.fda.gov/cder/orange/appendix_a.txt
APPENDIX A PRODUCT NAME INDEX ** 0 ** 0, AMOXICILLIN ** 8 ** 8-HOUR BAYER, ASPIRIN (OTC) 8-MOP, METHOXSALEN ** A ** A-HYDROCORT, HYDROCORTISONE SODIUM SUCCINATE A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE A-N STANNOUS AGGREGATED ALBUMIN, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT A-POXIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE A.P.L., GONADOTROPIN, CHORIONIC A/T/S, ERYTHROMYCIN ABELCET,...
Prescription and OTC Drug Product List 11/1998
Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 11: November 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE CLOBETASOL PROPIONATE TABLET; ORAL OINTMENT; TOPICAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN EMBELINE - ADD - ENDO PHARMS 400MG;5MG N40288 001 - ADD - AB...
Prescription and OTC Drug Product List 6/1999
Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 6: June 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AMINO ACIDS TABLET; ORAL INJECTABLE; INJECTION PERCOCET NOVAMINE 8.5% - ADD - AA ENDO PHARMS 325MG;5MG N40330 002 - DLT - @ PHARMACIA AND UPJOHN 8.5% N17957 002...
Prescription Drug Product List 1/96
PRESCRIPTION DRUG PRODUCT LIST 16TH EDITION RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / JAN'96 ACETAMINOPHEN; CODEINE PHOSPHATE CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE TABLET; ORAL - ADD - ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION; INTRAPERITONEAL - ADD - AA MIKART 300MG;60MG N89244 001 - ADD - DELFLEX W/ DEXTROSE 4.25% IN...
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...
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...
jlta224.tmp
CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: Application Number : 020184 / S003 Trade Name : ACEON CAPSULES Generic Name: Perindoppril Erbumine Capsules 2mg, 4mg and 8mg Capsules Sponsor : Rhone Poulenc Roher Approval Date: January 8, 1997 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION 020184/ S003 CONTENTS Included Pending Not Not Completion...
author: fda
jlta224.tmp
CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: Application Number : 020184 /S003 Trade Name : ACEON CAPSULES Generic Name: Perindopril erbumine Sponsor : Rhone Poulenc Rorer Approval Date: January 8, 1996 CENTER FOR DRUG EVALUATION AND RESEARCH Application Number 020184/ S003 APPROVAL LETTER ,*; cmcP* %, .- DESCRIPTION ACEON@ (perindopril ...
author: fda
1997 New Drug Application (NDA)
Approved Posted Aceon Capsules/Perindoppril Erbumine 2 mg, 4mg and 8 mg [940 KB] Rhone Poulenc Roher 020184/S003 1/8/1997 3/20/1998 Acephen G & W Labs 018060/S55 03/31/1997 9/11/2003 Acular PF/Ketorolac Tromethamine [5.5 MB] Hoffman-LaRoche 020811 11/3/1997 3/20/1998 Alesse Wyeth-Ayerst Laboratories 020683 3/27/1997 8/13/03 Allegra-D/Fenofenadine/pseudoephedrine Approval...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
4Q2003 TYPE2ACTIVETEXT DMF # SUBMIT DATE HOLDER SUBJECT 131 01-Jan-40 CENTRAL SOYA SOYBEAN STEROL PRODUCTS 183 29-Feb-52 INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 191 24-Jan-56 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE) 240 11-Jan-57 PHARMACIA & UPJOHN 19-NOR-ETHINYLTESTOSTERONE 281 21-Nov-57 UNIMED PHARMACEUTICALS INC 2 HYDROXY...
Generic Names of Some Trade Name Drugs, THE MERCK MANUAL OF HEALTH & AGING
Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs -~ Generic Names of Some Trade Name Drugs - Generic Names of Some...
Some Trade Names of Generic Drugs, THE MERCK MANUAL OF HEALTH & AGING
Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs-~ Generic Names of Some Trade Name Drugs - Some Trade Names of...
Angiotensin-converting enzyme (ACE) inhibitors - [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 Angiotensin-converting enzyme (ACE) inhibitors - [Medication] - Quest Diagnostics Patient Health Library Angiotensin-converting enzyme (ACE) inhibitors - [Medication] - Quest Diagnostics Patient Health Library Accupril, ACE, ACE Inhibitors, Aceon, ...
ACE inhibitors for high blood pressure - [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 ACE inhibitors for high blood pressure - [Medication] - Quest Diagnostics Patient Health Library ACE inhibitors for high blood pressure - [Medication] - Quest Diagnostics Patient Health Library Accupril, ACE, ACE Inhibitors, Aceon, AI, Altace,...
Angiotensin-converting enzyme (ACE) inhibitors - [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 Angiotensin-converting enzyme (ACE) inhibitors - [Medication] - Quest Diagnostics Patient Health Library Angiotensin-converting enzyme (ACE) inhibitors - [Medication] - Quest Diagnostics Patient Health Library Accupril, ACE, ACE Inhibitors, Aceon, ...
ACE inhibitors for high blood pressure - [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 ACE inhibitors for high blood pressure - [Medication] - Quest Diagnostics Patient Health Library ACE inhibitors for high blood pressure - [Medication] - Quest Diagnostics Patient Health Library Accupril, ACE, ACE Inhibitors, Aceon, AI, Altace,...
Angiotensin-converting enzyme (ACE) inhibitors for coronary artery disease - [Medication] - Quest Diagnostics Patient Health
Angiotensin-converting enzyme (ACE) inhibitors for coronary artery disease Examples Brand Name Chemical Name Capoten captopril Vasotec enalapril maleate Prinivil, Zestril, Zestoretic lisinopril Lotensin benazepril hydrochloride Monopril fosinopril sodium Accupril quinapril hydrochloride Mavik trandolapril Altace ramipril Aceon perindopril How It Works Angiotensin...
Drug Approvals - A
This newly approved or tentatively approved drug listing is an interim page intended to provide timely information on new drug products as a more comprehensive page is developed NDA 18-662/S-038 5/1/00 1/17/01 - - Acebutolol Hydrochloride Capsules,200 mg (base) and 400 mg (base) ANDA 75-047 12/30/99 1/3/00 - - Aceon (perindopril erbumine) Tablets, Solvay...
C:\Documents and Settings\sermona\My Documents\Letters\2003\NDA Le\ tters\20184s009.doc page 1
author: Alisea Sermon
ACEON® - FAQ
FAQ ACEON ® Tablets 1 Is ACEON ® Tablets a prescription product What is the suggested dosage for ACEON ® Tablets Is ACEON ® Tablets available in other countries What is ACEON ® Tablets In a pivotal study, ACEON ® Tablets demonstrated approximately equivalent blood pressure reduction at 6 and 24 hours after...
ACEON® - Fact Sheet
FACT SHEET ACEON ® (perindopril erbumine) Tablets Overview of ACEON ® (pronounced ace-e-on) Tablets ACEON ® Tablets is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of essential hypertension Based on pivotal clinical trials, ACEON ® (perindopril erbumine) Tablets has been shown to be efficacious and...
Solvay Pharmaceuticals - ACEON® FAQ
What is ACEON ® Tablets Is ACEON ® Tablets indicated for any other conditions Are there any known side effects associated with ACEON ® Tablets Based on clinical experience, ACEON ® Tablets has been shown to be effective and well-toleratedACEON ® Tablets is Solvay Pharmaceuticals' first cardiovascular product in the U.S....
Solvay Pharmaceuticals - Business Development
BUSINESS DEVELOPMENT Company Profile - Solvay Pharmaceuticals, Inc Operations in the United States include manufacturing facilities, full clinical and pharmaceutical development capabilities, selective research endeavors, and all marketing and sales functions Key marketed products in our portfolio are ACEON ® (perindopril erbumine) Tablets, ESTRATEST® and...
Solvay Pharmaceuticals - Alliances
SOLVAY PHARMACEUTICALS PATIENT ASSISTANCE PROGRAM Contact Information Patient Hotline: 1-800-256-8918 Physician Requests: AmeriCares’ Solvay Pharmaceuticals, Inc Louis, MO 63166-6650 Physicians apply on behalf of the patient by submitting a written request on an application form Ongoing patient participation is available based on continued medical and financial need
Solvay Pharmaceuticals - ACEON®
- FACT SHEET ACEON ® (perindopril erbumine) Tablets Overview of ACEON ® (pronounced ace-e-on) Tablets ACEON ® Tablets is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of essential hypertension Based on pivotal clinical trials, ACEON ® (perindopril erbumine) Tablets has been shown to be efficacious...