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...
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 SERTRALINE HYDROCHLORIDE PFIZER 19-839 SE1 045 22-Jan-02 7-Feb-03 12.5 Provides for the use of Zoloft (sertraline hydrochloride) Tablets for the treatment of social anxiety disorder as a new indicationSERTRALINE HYDROCHLORIDE PFIZER 20-990 SE1 011 22-Jan-02 7-Feb-03 12.5 Provides for the use of Zoloft (sertraline hydrochloride) Oral Concentrate for the...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt MELOXICAM JETMILLED AS MFG IN BIBERACH/RIB GERMANY 14432 30-Sep-99 ASAHI GLASS CO LTD PAROXETINE HYDROCHLORIDE AMORPHOUS AS MANUFACTURED IN ICHIHARA CITY CHIBA JAPAN 14436 05-Oct-99 FERMIC SA DE CV CLAVULANATE POTASSIUM AS MANUFACTURED IN MEXICO CITY MEXICO 14437 05-Oct-99 CIPLA LTD SERTRALINE HYDROCHLORIDE AS MANUFACTURED IN MAHARASHTRA INDIA 14439 23-Jun-99 SANYO...
http://www.fda.gov/cder/dmf/text/4Q2003NEWTEXT.txt CHINA." 16810 II 20-Aug-2003 ALPHARMA APS "TOBRAMYCIN SULFATE, USP STERILE AS MANUFACTUREED IN COPENHAGE, DENMARK" 16812 II 28-Aug-2003 "CAMBRIDGE MAJOR LABORATORIES, INC." "FP-043 AS MANUFACTURED IN GERMANTOWN, WI." 16813 II 3-Sep-2003 UCB BIOPRODUCTS "DESMOPRESSIN (ACETATE) AS MANUFACTURED IN BRAINE-L'ALLEUD, BELGIUM." 16818 II 26-Aug-2003 KUMAR ORGANIC PRODUCTS LIMITED "TRICLOSAN...
http://www.fda.gov/cder/dmf/xls/4Q2003NEWEXCEL.xls II RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA SERTRALINE HYDROCHLORIDE FORM II AS MANUFACTURED IN CAMPOVERDE DI APRILIA (LT), ITALYHYDROCHLORIDE AS MANUFACTURED IN ANDHRA PRADESH, INDIA II NICHOLAS PIRAMAL INDIA LTD ITRACONAZOLE AS MANUFACTURED IN...
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004 - INJECTION Approved 4/23/2001- PHENYTOIN SODIUM 200 MG, 300 MG - 00P-1462/CP1 LACHMAN CONSULTANT SERVICES - CAPSULE, EXTENDED RELEASE; ORAL Approved 2/13/2000- SERTRALINE HYDROCHLORIDE 25MG, 50MG, 100MG - 00P-1468/CP1 LACHMAN CONSULTANT SERVICES - CAPSULE; ORAL Approved 7/3/2002- AMINO ACIDS 10% 1000mL & 2000mL - 00P-1470/CP1 BAXTER HEALTHCARE CORP - INJECTION Approved 1...
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004 - CREAM; TOPICAL Denied 7/3/2002- LOPERAMIDE HYDROCHLORIDE 1 MG - 02P-0424/CP1 BANNER PHARMACAPS - CAPSULE; ORAL Approved 4/14/2003- LOPERAMIDE HYDROCHLORIDE 2 mg - 02P-0380/CP1 BANNER PHARMACAPS - SOFT GELATIN CAPSULES Pending - MERCAPTOPURINE 100 MG - 00P-1645/CP1 McKENNA & CUNEO - TABLET; ORAL Approved 4/17/2001- METFORMIN HYDROCHLORIDE 1000 MG - 03P-0388/CP1...
20990_Zoloft.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Zoloft (Sertraline Hydrochloride) Oral Comcentrate Company:- Pfizer Pharmaceuticals Application No.:- 020990 Approval Date:-12/07/99 - Approval Letter(s) - Printed Labeling - Medical Review(s) - Chemistry Review(s) & Microbiology Review(s) - Clinical Pharmacology...
author: Paul Stauffer
19-839S026_Zoloft.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Zoloft (Sertraline Hydrochloride) Tablets Company:- Pfizer Inc
author: Paul Stauffer
FDA Drug Approvals List October 2001 - Drug Approvals for October 2001 Definitions and Notes Original New Drug Applications Original Application #: 021356 Approval Date: 26-OCT-01 Trade Name: VIREAD Chemical Type: 1 Therapeutic Potential: P Dosage Form: TABLET Applicant: GILEAD SCIENCES INC Active Ingredient(s): TENOFOVIR DISOPROXIL FUMARATE OTC/RX Status: RX Indication(s): For use in combination with other...
FDA Drug Approvals List February 2001 Approvable Original New Drug Applications - Original Abbreviated New Drug Applications Original Abbreviated Application # 075402 Approval Date: 28-FEB-01 Trade Name: METAPROTERENOL SULFATE Dosage Form: SOLUTION Applicant: NOVEX PHARMA Active Ingredient(s): METAPROTERENOL SULFATE OTC/RX Status: RX Original Abbreviated Application # 075403 Approval Date: 28-FEB-01 Trade Name:...
Export Products List by System July 2003 page 42
author: Lee S. Ehler
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s ----------- This list is updated quarterly.- Updated through 12/31/02 -------------------- Top of Page ---------- EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE8)* Top of Page GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE GLAXOSMITHKLINE 21-205 SE8...
author: Darlene Norris
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 ...
Patent Patent Status – PCT Patent Pub. Date Filed Title WO02051408A1 07/04/2002 12/21/2001 AZOLE COMPOUNDS AS ANTI-FUNGALS AGENTS WO0247607A2 06/20/2002 12/07/2001 PROCESS FOR THE PREPARATION OF A FAST ...
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ranbaxy - - - - - You are here :- Home - International Operations - - Global API- Products PRODUCTS Anti-Infectives Semi-synthetic Penicillins Amoxycillin Trihydrate Ampicillin Trihydrate Cloxacillin Sodium ...
Efficacy Supplements Approved in Calendar Year 2001 (SE1-SE7 AND SE8S) -------------------- Top of Page -------- Last Updated on 1/28/02 ---- --- By CDER.USER EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2001 (SE8)* Top of Page GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPP TYPE SUPP NUMBER PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) ADENOSINE FUJISAWA HLTHCARE 20-059 11-Aug-99 31-Aug-01 SE8 007 N 24.7 ATORVASTATIN CALCIUM PFIZER...
author: Darlene Norris
ranbaxy - - - - - - You are here : Home - Products - - APIs GLOBAL API Active Pharmaceutical Ingredients(API) Ranbaxy's Global API business is a combination of commodity and technology products operating in regulated ...
FDA Drug Approvals List- April 1999 Original Application #: 050760 Approval Date: 15-APR-99 Trade Name: AMOXIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: SUSPENSION Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): AMOXICILLIN OTC/RX Status: RX Indication(s):For the use of Amoxil for oral suspension 200mg/5mL and 400mg/5mL in divided doses q12h Original Application #: 020924 Approval Date:...
http://www.fda.gov/cder/rdmt/escy99ap.htm - - - - - - - - - - TERBINAFINE HYDROCHLORIDE NOVARTIS 20-980 03/30/98 03/09/99 N 0 N 11.3 Rx to OTC switch for the treatment of tinea pedis (athlete's foot), tinea cruris (jock itch) and tinea corporis (ringworm)HYDROCHLORIDE SKB PHARMS 20-031 05/06/98 05/11/99 SE1 23 N 12.2 Treatment of social anxiety disorder
author: Darlene
http://www.protocare.com/files/Publications/Report_-_Full_List_of_Publications.PDF ID Protocare Trials Principal Investigator( s) Journal or Publication Reference Title of Article Therapeutic Area PROTOCARE TRIALS' INVESTIGATOR PUBLICATIONS 82 Am J Clin Nutr 2001: 74: 33- 43 Lipid responses to plant- sterol- enriched reduced- fat spreads incorporated into a National Cholesterol ...
http://www.protocare.com/files/Publications/Report_-_Full_List_of_Publications.PDF page 4 ID Protocare Trials Principal Investigator( s) Journal or Publication Reference Title of Article Therapeutic Area PROTOCARE TRIALS' INVESTIGATOR PUBLICATIONS 35 Journal of Clinical Psychiatry 2000 Oct: 173- 178 Depression: Diagnosis and Management for the Primary Care Physician CNS James ...
FDA Drug Approvals List December 1999 Original Application #: 020965 Approval Date: 03-DEC-99 Trade Name: LEVULAN KERASTICK Chemical Type: 1 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: ELINES, INCORPORATED Active Ingredient(s): AMINOLEVULINIC ACID HCL OTC/RX Status: RX Indication(s): For the use with a blue light irradiation using the BLU-U Illuminator for the photodynamic therapy of actinic keratoses of...
