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 2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO,...
Prescription and Over-the-Counter Drug Product List: 8/2003 4 >D> AA + ORTHO MCNEIL PHARM 300MG;60MG N85055 004 AUG DISC >A> @ 300MG;60MG N85055 004 AUG DISC ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA + MALLINCKRODT 500MG/15ML;10MG/15ML N40508 001 AUG 29, 2003 AUG NEWA >D> MIKART 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG CTEC >A> AA 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 4/2003 45 -D- XCEL PHARMS 1MG/ML N05929 001 APR CFTG -A- AP + 1MG/ML N05929 001 APR CFTG -A- DIHYDROEROGTAMINE MESYLATE -A- AP PADDOCK 1MG/ML N40475 001 APR 28, 2003 APR NEWA DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL -A- TAZTIA XT -A- AB4 ANDRX PHARMS 120MG N75401 001 APR 10, 2003 APR NEWA -A- AB4 180MG N75401 002 APR 10, 2003 APR NEWA -A- AB4 240MG N75401 003 APR...
author: AUTHOR
First-Time Generics - April 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - April 2003 - Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP 120 MG, 180 MG, 240 MG, 300 MG, AND 360 MG (ONCE-A-DAY DOSAGE) ANDRX PHARMACEUTICALS, L.L.PTIAZAC EXTENDED...
author: OGD
FDA Drug Approvals List March 2001 Original Application #: 021082 Approval Date: 01-MAR-01 Trade Name: TAVIST ALLERGY/SINUS/HEADACHE Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET Applicant: NOVARTIS CONSUMER HEALTH INC Active Ingredient(s): ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE OTC/RX Status: OTC Indication(s): For temporary relief of symptoms associated with hay fever...
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 Name:...
Prescription and OTC Drug Product List 10/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 10: October 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE BENZYL PENICILLOYL-POLYLYSINE CAPSULE; ORAL INJECTABLE; INJECTION BUTALBITAL, ACETAMINOPHEN AND CAFFEINE PRE-PEN - ADD - AB WEST WARD 500MG;50MG;40MG N40261...
FDA Drug Approvals List- January 1998 Drug Approvals for January 1998 Definitions and Notes January 1998 Original New Drug Applications Original Application #: 050731 Approval Date: 30-JAN-98 Trade Name: DAUNORUBICIN HCL Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC Active Ingredient(s): DAUNORUBICIN HYDROCHLORIDE OTC/RX Status: RX...
FDA Drug Approvals List March 2000 Original Application #: 021124 Approval Date: 17-MAR-00 Trade Name: LAMISIL Chemical Type: 6 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: NOVARTIS PHARMACEUTICALS CORP DBA SANDOZ PHARMACEUTICALS CORP Active Ingredient(s): TERBINAFINE HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the treatment of interdigital-type pedis (athlete’s foot), tinea cruris (jock...
FDA Drug Approvals List- October 1998 Drug Approvals for October 1998 Definitions and Notes October 1998 Original New Drug Applications Original Application #: 020926 Approval Date: 30-OCT-98 Trade Name: RENAGEL Chemical Type: 1 Therapeutic Potential: S Dosage Form: CAPSULE Applicant: GELTEX PHARMACEUTICALS INC Active Ingredient(s): SEVELAMER HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the reduction of serum...
DDPA November 1995 DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER TRADE NAME APPLICANT ACTIVE INGREDIENT(S) APPROVAL DATE (DOSAGE FORM) STRENGTH(S) (CLASSIFICATION) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-401 TIAZAC BIOVAIL DILTIAZEM HYDROCHLORIDE 11-SEP-95 (CAPSULE, SCARBOROUGH, ONTARIO 120MG (3 S) EXTENDED RELEASE)...
DDPA August 1995 20-401 TIAZAC BIOVAIL DILTIAZEM HYDROCHLORIDE 01-AUG-95 (CAPSULE, SCARBOROUGH, ONTARIO 120MG EXTENDED RELEASE) CANADA 180MG 240MG 300MG 360MG (CALCIUM ION INFLUX INHIBITOR) [HYPERTENSION] 20-465 AZULFIDINE EN-TABS KABI PHARMACIA SULFASALAZINE 02-AUG-95 (TABLET, COLUMBUS, OH 500MG DELAYED RELEASE) 43216 (ANTI-INFLAMMATORY) [TREATMENT OF RHEUMATOID ARTHRITIS] 50-673...
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...
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...
Latest News Stock Watch Earnings Estimate Fundamentals Shareholder Reports Webcasts Regulatory Filings Corporate Governance Executive Team Affiliated Companies Press Room Analysts Request Investor Information Biovail Reports Second Quarter 2004 Financial Results TORONTO--(BUSINESS WIRE)--Aug.
Latest News Stock Watch Earnings Estimate Fundamentals Shareholder Reports Webcasts Regulatory Filings Corporate Governance Executive Team Affiliated Companies Press Room Analysts Request Investor Information Biovail and Depomed Announce Glumetza NDS Acceptance TORONTO & MENLO PARK, Calif.--(BUSINESS WIRE)--Aug.Tiazac (diltiazem HCl) which, as a non...
Latest News Stock Watch Earnings Estimate Fundamentals Shareholder Reports Webcasts Regulatory Filings Corporate Governance Executive Team Affiliated Companies Press Room Analysts Request Investor Information Biovail Announces Regulatory Approval of Tiazac XC to Treat Hypertension in Canada TORONTO--(BUSINESS WIRE)--Aug.diltiazem HCl) represents a further advance in...
Latest News Stock Watch Earnings Estimate Fundamentals Shareholder Reports Webcasts Regulatory Filings Corporate Governance Executive Team Affiliated Companies Press Room Analysts Request Investor Information Biovail's Supplemental NDS For TIAZAC XC Accepted For Review by Therapeutic Products Directorate in Canada TORONTO--(BUSINESS WIRE)--Oct.
Latest News Cardizem LA prescription volume increased 40% for the third quarter of 2004 and 168% for the first nine months of 2003, versus the comparable periods in 2003, as Cardizem LA continued to gain market share in the once-daily diltiazem market.diltiazem market has increased 22.5%.
Latest News Stock Watch Earnings Estimate Fundamentals Shareholder Reports Webcasts Regulatory Filings Corporate Governance Executive Team Affiliated Companies Press Room Analysts Request Investor Information Biovail Launches Tiazac XC To Canadian Physicians TORONTO--(BUSINESS WIRE)--Jan.diltiazem hydrochloride that...
Latest News The key performance drivers for BPC were Wellbutrin SR and Tiazac. Tiazac increased 16% in the fourth quarter of 2004, compared with the same period in 2003.Tiazac XC, its once-daily extended-release formulation of diltiazem for the treatment of...
Latest News Stock Watch Earnings Estimate Fundamentals Shareholder Reports Webcasts Regulatory Filings Corporate Governance Executive Team Affiliated Companies Press Room Analysts Request Investor Information Court Rules in Favor of Biovail in Tiazac Class Actions TORONTO, Apr 04, 2005 (BUSINESS WIRE) -- Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today that a United States District...
Latest News These categories are as follows: Core Products -- includes Cardizem LA, Zovirax products and Teveten products Wellbutrin XL -- identified as a separate line for ease in tracking Biovail Pharmaceuticals Canada (BPC) -- including Tiazac, Wellbutrin SR and Zyban Legacy Products -- includes Tiazac (brand and generic), Cardizem CD (brand) Ativan/Isordil, Vasotec/Vaseretic,...
