Teva Pharmaceutical Industries - News and PR
- - Search Tevapharm: - - Press Release Teva Announces Final Approval for Quinapril Hydrochloride Tablets Jerusalem, Israel, June 2, 2003 - Teva Pharmaceutical Industries Ltd. Food and Drug Administration has granted final approval for the companys ANDA for Quinapril HCl Tablets, 5 mg, 10 mg, 20 mg and 40 mg. As the first company to file an ANDA with a...
Drug Approvals - A
Accupril and Accuretic (quinapril hydrochloride & hydrochlorothiazide) Tablets,- Pfizer Inc NDA 19-885/S23 & 20-125/S3 10/29/03 11/5/03 - - - Accupril (quinapril hydrochloride) Tablets,- Pfizer Inc NDA 19-885/S-019 7/22/02 7/24/02 - - Accupril (quinapril hydrochloride) Tablets ANDA 75-819 9/11/02 Amantadine Hydrochloride Syrup USP,...
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
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...
First-Time Generics - May 2003
Food and Drug Administration Center for Drug Evaluation and Research Drug Information Search First-Time Generics - May 2003 - Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 MOEXIPRIL HYDROCHLORIDE TABLETS 7.5 MG AND 15 MG TEVA PHARMACEUTICALS USA UNIVASC TABLETS 5/8/2003- 2 BETAMETHASONE DIPROPIONATE GEL 0.05% (BASE) ALTANA INC DIPROLENE GEL 5/13...
author: OGD
Prescription and Over-the-Counter Drug Product List: 5/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
FDA Drug Approvals List June 2001
PERRIGO COMPANY Active Ingredient(s): MONOXIDIL OTC/RX Status: RX Original Abbreviated Application # 075750 Approval Date: 8-JUN-01 Trade Name: DOXAZOSIN MESYLATE Dosage Form: TABLET Applicant: SIDMAK LABORATORIES, INC Active Ingredient(s): DOXAZOSIN MESYLATE OTC/RX Status: RX Original Abbreviated Application # 075502 Approval Date: 05-JUN-01 Trade Name: CLOTRIMAZOLE AND...
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...
FDA Drug Approvals List July 2002
45 Dosage Form: INJECTABLE Applicant: XCEL PHARMACEUTICALS Active Ingredient(s): DIHYDROERGOTAMINE MESYLATE OTC/RX Status: RX Application #: 020449 Labeling Supplement #: 019 To Original New Drug Application Approval Date: 30-JUL-02 Trade Name: TAXOTERE Dosage Form: INJECTABLE Applicant: AVENTIS PHARMACEUTICALS INC Active Ingredient(s): DOCETAXEL OTC/RX Status: RX Application #:...
http://www.tevapharm.com/pdf/teva6kq22003_isa.pdf
FORM 6- K SECURITIES AND EXCHANGE COMMISSION Washington, D. 4 Intersegment 75. District Court for the District of New Jersey, which held that Teva USA's Moexipril Hydrochloride Tablets did not infringe a U. In May 2003, following FDA approval, the Company launched its product, Moexipril Hydrochloride, 7.5 mg./ 15 mg. In connection with this transaction, the...
author: ami alcalay
http://www.fda.gov/cder/foi/label/2001/19885s18lbl.pdf
1 Accupril ® (Quinapril Hydrochloride Tablets) USE IN PREGNANCY hen used in pregnancy during the second and third trimesters, ACE inhibitors can cause in ury and even death to the developing fetus Ava lable data from cl n cal tr als of ACCUPRIL are nsuff c ent to show that, n pat ents w thout pr or react ons to other ACE nh b tors, ACCUPRIL does...
http://www.fda.gov/cder/foi/label/2001/19885s18lbl.pdf page 1
Microsoft Word - 75504ltr.doc
ANDA 75- 504 February 8, 2002 TEVA Pharmaceuticals USA Attention: Philip Erickson 1090 Horsham Road P Box 1090 North Wales, PA 19454 Dear Sir: This is in reference to your abbreviated new drug application dated November 20, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Quinapril Hydrochloride Tablets, 5 mg, 10 mg, 20...
author: staufferp
Microsoft Word - 75504ltr.doc page 1
author: staufferp
FDA Drug Approvals List- February 1998
Drug Approvals for February 1998 Definitions and Notes February 1998 Original New Drug Applications Original Application #: 050750 Approval Date: 24-FEB-98 Trade Name: ZOSYN Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: LEDERLE PIPERACILLIN INC DIV AMERICAN CYANAMID CO Active Ingredient(s): PIPERACILLIN SODIUM; TAZOBACTAM SODIUM OTC/RX Status: RX...
FDA DRUG AND DEVICE PRODUCT APPROVALS
74-776 TIMOLOL MALEATE BAUSCH AND LOMB TIMOLOL MALEATE 26-JUL-96 (SOLUTION/DROPS) TAMPA, FL 0.5% 33637 (BETA ADRENERGIC BLOCKER) 74-778 TIMOLOL MALEATE BAUSCH AND LOMB TIMOLOL MALEATE 26-JUL-96 (SOLUTION/DROPS) TAMPA, FL 0.25% 33637 (BETA ADRENERGIC BLOCKER) 74-465 TIMOLOL MALEATE ADV REMEDIES TIMOLOL MALEATE 30-JUL-96 (SOLUTION/DROPS) SOMERSET, NJ 0.25% 08873 (BETA ADRENERGIC...
DDPA April 1996
***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 20-262 TAXOL BRISTOL MYERS SQUIBB PACLITAXEL 01-APR-96 (INJECTABLE) WALLINGFORD, CT 6MG/ML 06492 (LABELING REVISION -- BOXED WARNING; DESCRIPTION; WARNINGS; PRECAUTIONS; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION; HOW SUPPLIED) 18-602 CARDIZEM HOECHST MARION RSSL DILTIAZEM HYDROCHLORIDE 02-APR-96 (TABLET) KANSAS CITY, MO 30MG 64134...
July Drug Approvals
Drug Approvals for July 1996 Definitions and Notes Original New Drug Application Original Application #: 020538 Approval Date: 31-JUL-96 Trade Name: ESTRADIOL Chemical Type: Already marketed drug product but a new manufacturer Therapeutic Potential: Standard review drug Dosage Form: FILM, EXTENDED RELEASE Applicant: MENOREST MANFACTURING INC Active Ingredient(s): ESTRADIOL OTC/RX...
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...
Nephrotic Syndrome: Nephritis: Merck Manual Home Edition
Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, ABBOKINASE to BUTAZOLIDIN
Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS ABBOKINASE to BUTAZOLIDIN Trade Name Generic ABBOKINASE Urokinase ACCOLATE Zafirlukast ACCUPRIL Quinapril ACCUTANE Isotretinoin ACHROM YCIN V Tetracycline ACTHAR Corticotropin (ACTH) ACTIFED *Triprolidine ADALAT Nifedipine ADENOCARD Adenosine ADRIAMYCIN Doxorubicin ADVIL Ibuprofen AFRIN...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Paclitaxel to Rosiglitazone
Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Paclitaxel to Rosiglitazone Generic Trade Name Paclitaxel TAXOL Pamidronate AREDIA Pancrelipase PANCREASE, VIOKASE Pancuronium PAVULON Papaverine PAVABID Paramethadione PARADIONE Paramethasone HALDRONE Pargyline EUTONYL Paromomycin HUMATIN Paroxetine PAXIL Penbutolol LEVATOL Penciclovir DENAVIR...
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,...