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  Current Search:  quinapril: 181, hydrochloride: 3359  
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Teva Pharmaceutical Industries - News and PR
- - Search Tevapharm: - - Press Releases 2004 - 2005: Teva Announces Approval Of Methylprednisolone Acetate Injectable Suspension Jerusalem, Israel, February 24, 2005 Teva and Lundbeck Announce European Approval for AZILECT® (rasagiline) 1mg for Parkinson's Disease Jerusalem, Israel and Copenhagen, Denmark, February 22, 2005 Teva Announces Settlement Of Lamictal® Litigation...
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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 company’s ANDA for Quinapril HCl Tablets, 5 mg, 10 mg, 20 mg and 40 mg.
As the first company to file an ANDA with a...
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Teva Pharmaceutical Industries - News and PR
Jerusalem, Israel, and Hawthorne, NY, September 23, 2003, September 23, 2003 Teva Announces Approval of Nefazodone HCl Tablets 50 mg, 100 mg, 150 mg, 200 mg and 250 mg Jerusalem, Israel, September 16, 2003 Teva Announces NDA Submission of Rasagiline as a Treatment for Parkinson's Disease Jerusalem, Israel, September 8, 2003 Teva Announces Approval of Ofloxacin Tablets 200 mg, 300 mg,...
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Microsoft Word - NewYork_2683824_9.DOC
FORM 6- K SECURITIES AND EXCHANGE COMMISSION Washington, D.
The accompanying notes are an integral part of the condensed financial statements.
During September 2004, the Emerging Issues Task Force (" EITF") issued EITF Issue No.
8) (11.2) (44.5) (34.3) Other expenses (2.
As previously disclosed in Teva's Form 20- F for the year ended December 31, 2003 and Teva's Form 6- K...

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Microsoft Word - NewYork_2683824_9.DOC page 28


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Microsoft Word - NewYork_2683824_9.DOC page 14


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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, 50 mg and 5 mL...
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Drug Approvals - Q
Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Quinapril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Teva Pharmaceuticals 75-504 5/30/03 - - - Quinapril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Tentatively Approved Andrx Pharmaceuticals 76-049 6/11/03 - - - Quinapril Hydrochloride Tablets, 5, 10, 20 &...
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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...
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http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN PHENAPHEN-650 W/ CODEINE, ACETAMINOPHEN PHENAZINE, PHENDIMETRAZINE TARTRATE PHENAZINE-35, PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDE PHENERGAN PLAIN, PROMETHAZINE HYDROCHLORIDE PHENERGAN VC W/ CODEINE, CODEINE PHOSPHATE PHENERGAN VC, PHENYLEPHRINE HYDROCHLORIDE PHENERGAN W...

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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
LOUIS, MISSOURI" 12443 28-Mar-97 SCHERING PLOUGH PRODUCTS INC "STERILE WATER FOR INJECTION, MANUFACTURED IN MANATI, PUERTO RICO" 12444 26-Mar-97 ORION CORP FERMION "ENTACAPONE, MANUFACTURED IN HANKO AND ESPOO, FINLAND" 12445 18-Mar-97 NAPP TECHNOLOGIES INC "NABUMETONE, MANUFACTURED IN COVENTRY, RHODE ISLAND" 12449 03-Apr-97 PHARM ECO LABORATORIES INC "2-AMINO-5-PHENYL-4(5H)-OXAZOLONE...

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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
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ANDA Approvals May 2003
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - May 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 75-681 MEGESTROL ACETATE ORAL SUSPENSION, USP 40 MG/ML COPLEY PHARMACEUTICAL, INC
5/6/2003- 4 76-204 MOEXIPRIL HYDROCHLORIDE TABLETS 7.5 MG AND 15 MG TEVA PHARMACEUTICALS USA 5/8/2003- 5 76-224...
author: OGD
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Generic Tentative Approvals - June 2003
6/11/2003- 4 40-486 METAXALONE TABLETS 400 MG - COREPHARMA LLC 6/11/2003- 5 76-049 QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE) - ANDRX PHARMACEUTICALS, LLC 6/11/2003- 6 76-378 NIACIN EXTENDED-RELEASE TABLETS 500 MG, AND 750 MG - BARR LABORATORIES, INC
6/13/2003- 7 76-220 OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG -...
author: OGD
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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
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ANDA Tentative Approvals - February 2002
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - February 2002 - ANDA Number Drug Name Applicant Tentative Approval Date 1 76-067 MOMETASONE FUROATE OINTMENT, USP 0.1% CLAY-PARK LABS, INC
2/1/02 2 75-928 CIPROFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% NOVEX PHARMA 2/4/02 3 76-059 LISINOPRIL TABLETS, USP 2.5 MG, 5...
author: USERNAME
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Sigma Company
- - Sigma Pharmaceutical's own branded products are classified into major therapeutic areas: Analgesics Codalgin™ (codeine phosphate, paracetamol) Aspalgin™ (codeine phosphate, aspirin) Paralgin™ (paracetamol) Capadex™ (dextropropoxyphene HCl, paracetamol) Zyloprim (allopurinol) Antibiotics Cilamox™ (amoxycillin) Cilicaine™ (penicillin) Klacid® ...
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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...
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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...
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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 #:...
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FDA Drug Approvals List February 2002
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application#065022 Approval Date: 27-FEB-02 Trade Name: BACITRACIN ZINC AND POLYMYXIN B SULFATE Dosage Form: OINTMENT Applicant: ALTANA INC Active Ingredient(s): BACITRACIN ZINC; POLYMYXIN B SULFATE OTC/RX Status: RX Original Abbreviated Application# 075874 Approval Date: 26-FEB-02...
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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
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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
Inh b t on of the pressor response to ang otens n I s shorter- l ved, w th a 20 mg dose g v ng 75% nh b t on for about 4 hours, 50% nh b t on for about 8 hours, and 20%...

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http://www.fda.gov/cder/foi/label/2001/19885s18lbl.pdf page 1


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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
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