Microsoft Word - NewYork_2683824_9.DOC As previously disclosed in Teva's Form 20- F for the year ended December 31, 2003 and Teva's Form 6- K with respect to the quarter ended June 30, 2004, Teva USA commenced sales of its 7.5 mg and 15 mg Moexipril Hydrochloride Tablets in May 2003.moexipril hydrochloride...
Microsoft Word - 6-K United Final.doc FORM 6- K SECURITIES AND EXCHANGE COMMISSION Washington, D.
author: liat-r
Microsoft Word - 6-K United Final.doc page 12
author: liat-r
http://www.tevapharm.com/pdf/20-F_20040315.pdf page 128
http://www.tevapharm.com/pdf/20-F_20040315.pdf page 75
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 4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA...
Microsoft Word - 6k_all.doc District Court for the District of New Jersey, which held that Teva USA's Moexipril Hydrochloride Tablets did not infringe a U.moexipril formulation as Univasc. Moexipril Hydrochloride, 7.
author: Administrator
Microsoft Word - 6k_all.doc page 10
author: Administrator
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
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 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...
http://www.tevapharm.com/pdf/teva6kq22003_isa.pdf District Court for the District of New Jersey, which held that Teva USA's Moexipril Hydrochloride Tablets did not infringe a U.moexipril formulation as Univasc. Moexipril Hydrochloride, 7.5 mg./ 15 mg.
author: ami alcalay
http://www.tevapharm.com/pdf/teva6kq22003_isa.pdf page 21
author: ami alcalay
http://www.tevapharm.com/pdf/teva6kq22003_isa.pdf page 10
author: ami alcalay
FDA Drug Approvals List February 2000 Dosage Form: GRANULE Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV Active Ingredient(s): ERYTHROMYCIN ETHYLSUCCINATE OTC/RX Status: RX Application #: 020847 Labeling Supplement#: 002 To Original New Drug Application Approval Date: 04-FEB-00 Trade Name: ESCLIM Dosage Form: FILM, CONTROLLED RELEASE Applicant: WOMEN FIRST HEALTHCARE INC Active Ingredient(s): ESTRADIOL OTC...
FDA Drug Approvals List- April 1998 Application #: 020555 Efficacy Supplement#: 003 Type: SE1 to Original New Drug Application Approval Date: 01-APR-98 Trade Name: AXID AR Dosage Form: TABLET Applicant: WHITEHALL ROBINS HEALTHCARE Active Ingredient(s): NIZATIDINE OTC/RX Status: OTC Efficacy Claim: Provides for treatment of episodic heartburn, acid indigestion and sour stomach Application #: 020393 Efficacy Supplement#:...
DDPA April 1995 Drug and Device Approvals-April 1995 **ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-145 NITRO-DUR KEY PHARMS NITROGLYCERIN 04-APR-95 (FILM, KENILWORTH, NJ 0.1MG/HR (SUPPL-004)EXTENDED RELEASE) 07033 0.2MG/HR 0.3MG/HR 0.4MG/HR 0.6MG/HR 0.8MG/HR (VASODILATOR) [PREVENTION OF ANGINA PECTORIS] 19-829 CERETEC AMERSHAM TECHNETIUM TC-99M 07-APR-95 (INJECTABLE) ARLINGTON HEIGHTS...
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...
http://www.biosis.org/ts/media/cdjournals/gazettenews/2001/CPG_News_0144.pdf Israel’s Teva Pharmaceutical Industries has entered into a new legal wrangle in the US with Schwarz Pharma for alleged patent infringement of its hypertension drug, Univasc. moexipril hydrochloride, but on Monday Schwarz countered by filing suit...
Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Release Teva Announces Approval of Moexipril HCl Tablets Jerusalem, Israel, May 8, 2003 - Teva Pharmaceutical Industries Ltd.Moexipril HCl Tablets, 7.5 mg and 15 mg.
Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Release Teva Comments On The Court Of Appeals Decision Regarding Moexipril Jerusalem, Israel, January 31, 2004 - Teva Pharmaceutical Industries Ltd.Moexipril HCl Tablets would not infringe U.S.Moexipril HCl Tablets are the AB-rated generic...
Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Release Teva Enters Into Agreement With Schwarz Pharma to Suspend Sales of Moexipril Pending Outcome of Litigation Jerusalem, Israel, September 13, 2004 - Teva Pharmaceutical Industries Ltd.
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