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material_safety_data_sheet_letter_new_.doc
05% OCUFLOX® (Ofloxacin Ophthalmic Solution) 0.3% SANCTURA® (trospium chloride), 20 mg tablets Ofloxacin SANCTURA XR® (trospium chloride), 60 mg tablets OPHTHETIC® (Proparacaine HCl Ophthalmic Solution) 0.5% Trimethoprim Sulfate and Polymyxin B Sulfate, 0.1% OPTIVE™ Lubricant Eye Drops VIVITE™ Daily Antioxidant Facial Serum POLY- PRED® (...
author: hutton_ronald
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material_safety_data_sheet_letter_new_.doc page 2
author: hutton_ronald
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material_safety_data_sheet_letter_new_.doc page 1
author: hutton_ronald
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IROA - Scientific Study Reference Search
Pellets 2-Acetamidofluorene (2-AAF) 2-Acetylaminofluorene (AAF) 2-OHE1 3,3',5-Triiodo-L-Thyronine (T3) 4-Hydroxyandrostene-3,17-dione (4-OHA) 4-Hydroxyandrostenedione 5a-Androstan-3a + 17ss-diol 5a-Dihydrotestosterone (5a-DHT) 5a-Dihydrotestosterone (5a-DHT) 5a-Reductase Inhibitor (4MA) 5-Bromo-2'-Deoxyurdine (BrDU) 5a-Dihydrotestosterone (5a-DHT) 6-n-Propyl-2-Thiouracil (PTU...
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CDER Guidance Documents
(Issued 8/2000, Posted 8/8/2000) Joint Safety/Efficacy (Multidisciplinary) (Draft) Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001) [ PDF ] M4 Common Technical Document--Quality: Questions and Answers/Location Issues [ HTML ] or [ PDF ] or [ ] (Issued 9/12/2002, Posted 12/30/2002) Quality Q1E Evaluation of...
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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/ CODEINE, CODEINE...
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
AMIODARONE HCL 3506 24-Apr-79 BAXTER ONCOLOGY GMBH IFOSFAMIDE 3507 27-Apr-79 GEDEON RICHTER LTD VINCRISTINE SULFATE 3513 08-Mar-79 FABBRICA ITALIANI SINTETICI SPA FUROSEMIDE 3516 30-Mar-79 DINAMITE DIPHARMA SPA TRIAMTERENE USP XIX/BP '73 3524 08-Feb-79 DINAMITE DIPHARMA SPA "CYPROHEPTADINE HCL, USP" 3529 30-May-79 AVENTIS PHARMA SA PREDNISOLONE ACETATE 3531 14-Mar-79 ...
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http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
MEDI PHYSICS INC CYCLOTRON OPERATION, THALLOUS CL (TL-201), NORTH ARLINGTON, ILLINOIS DIOSYNTH BV MEDROXYPROGESTERONE ACETATE MICRO MEDI PHYSICS INC GALLIUM (GA 67) EMERYVILLE,CA; SOUTH PLAINFIELD,NJ; NORTH ARLINGTON,IL MEDI PHYSICS INC KRYPTON (KR 81m) EMERYVILLE,CA;SOUTH PLAINFIELD,NJ;NORTH ARLINGTON,ILL AVENTIS PHARMA SA METHYLPREDNISOLONE MANUF FOR ROUSSEL UCLAF BY DIOSYNTH...
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OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004
FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -OGD Suitability Tracking Report (Sorted by Petition Number) as of 1/5/2004 Drug/Strength Petition No/Firm Dosage Form Status Status Date ACETAMINOPHEN 300 MG HYDROCODONE BITARTRATE 5 MG, 7.5 MG, 10 MG - 03P-0436/CP1 ANABOLIC LABORATORIES - - - 9/22/2003- TRIPELENNAMINE HYDROCHLORIDE 25 MG/5...
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OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004
- SOLUTION; ORAL Approved 4/17/2001- HYDROCODONE POLISTIREX 5 MG, 10 MG CHLORPHENIRAMINE POLISTIREX 4 MG, 8 MG - 03P-0091/CP1 LACHMAN CONSULTANT SERVICES - EXTENDED RELEASE CAPSULES Pending - HYDROCORTISONE ACETATE 2% - 01P-0085/CP1 FERNDALE LABORATORIES INC
- CREAM; TOPICAL Approved 8/1/2001- HYDROCORTISONE ACETATE 2.5% - 01P-0511/CP1 FERNDALE LABORATORIES, INC
-...
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ANDA Approvals - September 2003
- FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Approvals - September 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 76-220 OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG - RANBAXY LABORATORIES LIMITED 9/2/2003- 2 76-093 OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG - PAR PHARMACEUTICAL, INC
9/9/2003- 11 40-313 ...
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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;10MG...
author: AUTHOR
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Prescription and Over-the-Counter Drug Product List: 6/2003
>D> AP + WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUN DISC >A> @ 5,000 UNITS/VIAL N17055 001 JUN DISC >D> AP + 10,000 UNITS/VIAL N17055 002 JUN DISC >A> @ 10,000 UNITS/VIAL N17055 002 JUN DISC GUANABENZ ACETATE TABLET; ORAL GUANABENZ ACETATE >D> AB WATSON LABS EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >A> AB + EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >D> WYTENSIN ...
author: AUTHOR
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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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Prescription and Over-the-Counter Drug Product List: 4/2003
45 -D- XCEL PHARMS 1MG/ML N05929 001 APR CFTG -A- AP + 1MG/ML N05929 001 APR CFTG -A- DIHYDROEROGTAMINE MESYLATE -A- AP PADDOCK 1MG/ML N40475 001 APR 28, 2003 APR NEWA DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL -A- TAZTIA XT -A- AB4 ANDRX PHARMS 120MG N75401 001 APR 10, 2003 APR NEWA -A- AB4 180MG N75401 002 APR 10, 2003 APR NEWA -A- AB4 240MG N75401 003 APR 10, 2003 APR...
author: AUTHOR
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Prescription and Over-the-Counter Drug Product List: 2/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL -A- CODRIX -A- + ANDRX PHARMS 500MG;15MG N40447 001 FEB 26, 2003 FEB NEWA AZATHIOPRINE TABLET; ORAL AZASAN -A- AAIPHARMA LLC 25MG N75252 002 FEB 03, 2003 FEB NEWA -A- AB 50MG N75252 001 JUN 07, 1999 FEB NEWA -A- 75MG N75252 003 FEB 03, 2003 FEB NEWA -A- 100MG N75252 004 FEB 03, 2003...
author: AUTHOR
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Efficacy Supplements Approved in Calendar Year 1998
DESMOPRESSIN ACETATE RHONE POULENC RORER 19-955 26-Mar-97 25-Mar-98 SE1 12.0 Primary nocturnal enuresis
ESTROGENS/ CONJUGATED MEDROXYPRO-GESTERONE ACETATE WYETH AYERST LABS 20-527 09-Jan-97 09-Jan-98 SE2 12.0 Treatment of moderate to severe vasomotor symptoms associated with the menopause; treatment of vulvar and vaginal atrophy; prevention of osteoporosis
GOSERELIN...
author: Brenda Harmon
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ANDA Approvals March 2003
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - March 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 40-455 NOREPINEPHRINE BITARTRATE INJECTION, USP 1 MG (BASE)/ML, PACKAGED IN 4 MG (BASE)/4 ML SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INC
3/3/2003- 2 40-463 ORPHENADRINE CITRATE INJECTION, USP...
author: OGD
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Prescription and Over-the-Counter Drug Product List: 3/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG;30MG N40441 001...
author: AUTHOR
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Alefacept (Amevive) Clinical Review page 26
author: CBER FDA
subject: dob062703
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1997 Abbreviated New Drug Applications (Generic Drugs)
Generic Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
64155, 64164, 64165, 64166 10/2/1997 4/1/1999 Cefuroxime Sodium 750 mg (base)/vial and 1.5 Gm (base)/vial, [5 MB] G.C
71804 5/29/1997 4/1/1999 Desmopressin Acetate Injection 4mg/ml [801 KB] Gensia Laboratories, Ltd
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http://www.fda.gov/cder/ogd/rld/RLD_LABELING_%20APPROVED_AUG_1998.HTML
20-408 S-013 Merck 03-Aug-1998 BLEPHAMIDE Prednisolone Acetate/Sulfacetamide Sodium Opth
Susp 12-813 S-043 Allergan 03-Aug-1998 PROVERA Medroxyprogesterone Acetate Tablets 11-839 S-068 Pharmacia And Upjohn 04-Aug-1998 OVCON-35 Ethinyl Estradiol/Norethindrone Tablets 18-127 S-033 Bristol-Myers Squibb 10-Aug-1998 OVCON-35 Ethinyl Estradiol/Norethindrone Tablets 17-716 S...
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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...
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FDA Drug Approvals List July 2002
- Drug Approvals for July 2002 Definitions and Notes Original New Drug Applications Original New Drug Application # 021409 Approval Date: 26-JUL-02 Trade Name: SINGULAIR Chemical Type: 3 Therapeutic Potential: S Dosage Form: GRANULE Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC Active Ingredient(s): MONTELUKAST SODIUM OTC/RX Status: RX Indication of Use: PROPHYLAXIS/CHRONIC...
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