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  Current Search:  nefazodone: 231, hydrochloride: 3359  

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Teva Pharmaceutical Industries - News and PR
- - Search Tevapharm: - - Press Release Teva Announces Approval of Nefazodone HCl Tablets 50 mg, 100 mg, 150 mg, 200 mg and 250 mg Jerusalem, Israel, September 16, 2003 - Teva Pharmaceutical Industries Ltd.
Food and Drug Administration has granted approval of the company's ANDA for Nefazodone Hydrochloride Tablets, 50 mg, 100 mg, 150 mg, 200 mg and 250 mg.
...
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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,...
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Database S
S - investigational drugs, therapies and vaccines # - 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 From this page you may order documents with information covering investigational products.
See TOCOSOL™ Camptothecin (3313) S-9156 (1729) S-3APG, See ENMD 0995 (2814) SA-IVIG (Staphylococcus Aureus-Hyperimmune Intravenous...
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Drug Approvals - N
NDA 20-388/S8 6/8/00 6/19/02 6/19/02 6/19/02 Nebcin (tobramycin sulfate injection, USP)-Vials and Hyporets, Rx Eli Lilly and Company NDA 50-477/S-024 & 50-519/S-024 4/2/03 4/18/03 Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Rx Ranbaxy ANDA 76-409 9/16/03 Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Rx, Tentatively Approved...
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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
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,...

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TEXT
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
LOUIS, MO" 13842 12-Nov-98 MEDICHEM SA "LORATADINE, MANUFACTURED IN GERONA, SPAIN" 13843 12-Nov-98 CHATTEM CHEMICALS INC "AMMONIUM LACTATE, MANUFACTURED IN CHATTANOOGA, TN" 13844 19-Nov-98 CHEMAGIS LTD "GRANISETRON HYDROCHLORIDE, MANUFACTURED IN BEER SHEVA, ISRAEL" 13845 16-Nov-98 NYCOMED AUSTRIA GMBH "4-METHOXYPHENOL, MANUFACTURED IN LINZ, AUSTRIA" 13846 29-Oct-98 BIDACHEM SPA...

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Microsoft Word - 6k_all.doc
FORM 6- K SECURITIES AND EXCHANGE COMMISSION Washington, D.
9) (3.
1 Total net sales $ 1, 549.
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.
and Canada product rights of which...

author: Administrator
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Microsoft Word - 6k_all.doc page 14


author: Administrator
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ANDA Approvals - September 2003
9/12/2003- 18 75-145 SELEGILINE HYDROCHLORIDE CAPSULES 5 MG - AAI PHARMA 9/15/2003- 19 75-763 NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG - IVAX PHARMACEUTICALS, INC
9/16/2003- 20 76-072 NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG - GENEVA PHARMACEUTICALS, INC
9/16/2003- 21 76-409 ...
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Prescription and Over-the-Counter Drug Product List: 9/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> + MIKART 325MG/15ML;7.5MG/15ML N40482 001 SEP 25, 2003 SEP NEWA ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET; ORAL >A> OXYCODONE AND ACETAMINOPHEN >A> AA WATSON LABS 325MG;7.5MG N40535 001 SEP 05, 2003 SEP NEWA >A> AA 325MG...
author: AUTHOR
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Generic Tentative Approvals - June 2003
6/10/2003- 3 75-763 NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG - IVAX PHARMACEUTICALS, INC
6/13/2003- 7 76-220 OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG - RANBAXY LABORATORIES LIMITED 6/17/2003- 8 76-304 FLUCONAZOLE INJECTION (IN 5% DEXTROSE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML FLEXIBLE PLASTIC CONTAINERS -...
author: OGD
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Tentative Approvals - July 2003
- FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Tentative Approvals - July 2003 - ANDA Number Generic Drug Name Applicant Tentative Approval Date 1 76-309 NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG - DR
REDDY'S LABORATORIES LIMITED 7/7/2003- 2 76-188 FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG,...
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Generic Tentative Approvals - October 2002
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - October 2002 ANDA Number Generic Drug Name Applicant Tentative Approval Date 1 75-183 PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 5 MG (BASE)/5 ML HI-TECH PHARMACAL CO., INC
10/17/02 2 75-268 OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG AND 20 MG GENPHARM INC author: OGD
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Generic Tentative Approvals -January 2003
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - January 2003 - ANDA Number Generic Drug Name Applicant Tentative Approval Date 1 75-823 CALCITRIOL INJECTION 0.001 MG/ML AND 0.002 MG/ML; 1 ML FILL IN 2 ML SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INC
1/2/03 2 76-162 CARBOPLATIN FOR INJECTION, USP 50 MG,...
author: OGD
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Efficacy Supplements Approved in Calendar Year 1998
DILTIAZEM HYDROCHLORIDE BIOVAIL LABS 20-401 30-Jan-97 30-Jan-98 SE1 12.0 Treatment of chronic stable angina
GEMCITABINE HYDROCHLORIDE LILLY 20-509 29-Aug-97 25-Aug-98 SE1 11.9 In combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer
IRINOTECAN ...
author: Brenda Harmon
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Generic Tentative Approvals -April 2003
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - April 2003 - ANDA Number Generic Drug Name Applicant Tentative Approval Date 1 76-042 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG GENPHARM INC
4/10/2003- 2 76-145 FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 200 MG/100 ML AND 400 MG/200...
author: OGD
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Roxane Laboratories: Product Information
PRESS RELEASES - September 16, 2003 ROXANE ANNOUNCES THE AVAILABILITY OF NEFAZODONE HYDROCHLORIDE TABLETS Prescribing Information July 21, 2003 ROXANE ANNOUNCES THE AVAILABILITY OF CALCITRIOL ORAL SOLUTION 1MCG/ML Prescribing Information June 19, 2003 ROXANE ANNOUNCES THE AVAILABILITY OF MIRTAZAPINE TABLETS 15MG, 30MG, 45MG Prescribing Information March 31, 2003 ROXANE...
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FDA Drug Approvals List December 2001
Active Ingredient(s): LISINOPRIL OTC/RX Status: RX Original Abbreviated Application #: 076058 Tentative Approval Date: 21-DEC-01 Trade Name: MIDAZOLAM HCL Dosage Form: SYRUP Applicant: RANBAXY LABORATORIES LTD Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Application #: 076134 Tentative Approval Date: 20-DEC-01 Trade Name: LORATADINE...
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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...
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FDA Drug Approvals List June 2002
- Drug Approvals for June 2002 Definitions and Notes Original New Drug Applications Original Application # 021316 Approval Date: 26-JUN-02 Trade Name: ALTOCOR Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: AURA LABORATORIES INC Active Ingredient(s): LOVASTATIN OTC/RX Status: RX INDICATION OF USE: For lowering total cholesterol and LDL-C to target levels as...
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FDA Drug Approvals List January 2002
Active Ingredient(s):LISINOPRIL OTC/RX Status: RX Original Abbreviated Application #: 076119 Tentative Approval Date: 15-JAN-02 Trade Name: MIRTAZAPINE Dosage Form: TABLET Applicant: TEVA PHARMACEUTICALS USA INC Active Ingredient(s): MIRTAZAPINE OTC/RX Status: RX Original Abbreviated Application #: 075977 Tentative Approval Date: 15-JAN-02 Trade Name: TRAMADOL HYDROCHLORIDE...
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Export Products List by System July 2003 page 42


author: Lee S. Ehler
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RLD_LABELING_ APPROVED_SEP_1999
Product Name Drug Name NDA No Supp.No Firm Date DOBUTAMINE Dobutamine In 5% Dextrose In Plastic 20-201 S-012 Abbott 01-Sep-1999 DEMULEN 1/35-21 Ethinyl Estradiol/Ethynodiol Diacetate Tablets 18-168 S-026 Searle 02-Sep-1999 DEMULEN 1/50-21 Ethynodiol Diacetate/Ethinyl Estradiol Tablets 16-927 S-062 Searle 02-Sep-1999 MIRAPEX Pramipexole Tablets 20-667 S-007 Pharmacia & Upjohn 03-Sep...
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Protocare.com
Publications For a complete listing of all publications in PDF format, click here. A Full Printable List of Publications Consumption of diacylglycerol oil as part of a reduced-energy diet enhances loss of ...
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