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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,...
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THE MERCK MANUAL, Sec. 5, Ch. 55, Crystal-Induced Conditions
This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 5.
Crystal-Induced C onditions Topics Gout Idiopathic Hyperuricemia Calcium Pyrophosphate Dihydrate Crystal Deposition Disease Basic Calcium Phosphate And Other Crystal Disorde rs Gout A recurrent acute or chronic arthritis of peripheral joints that results from deposition in and about the...
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http://www.merck.com/product/usa/pi_circulars/d/decadron/decadron_tblts_pi.pdf
For the purpose of comparison, the following is the equivalent milligram dosage of the various corticosteroids: Cortisone, 25 Triamcinolone, 4 Hydrocortisone, 20 Paramethasone, 2 Prednisolone, 5 Betamethasone, 0.75 Prednisone, 5 Dexamethasone, 0.75 Methylprednisolone, 4 These dose relationships apply only to oral or intravenous administration of these compounds.
In acute,...
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http://www.merck.com/product/usa/pi_circulars/d/decadron/decadron_tblts_pi.pdf page 7
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Drug Approvals - O
Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Ocufen Ophthalmic Solution, (0.03%) Allergan NDA 19-404/S020 8/25/03 8/28/03 8/28/03 - Ocufen Ophthalmic Solution (0.03%) Allergan NDA 19-404/S017 8/17/01 - 4/15/03 - Ocufen Ophthalmic Solution (0.03%) Allergan NDA 19-404/S014 7/30/01 - 4/15/03 - Ofloxacin Injection, 40 mg/mL packaged in 10 mL...
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Mercury in Drug and Biologic Products
Retired Persons Oxymetazoline Nasal Spray PMA.002 - American International Chemical Thimerosal (bulk chemical) TM 100 - American International Chemical Thimerosal (bulk chemical) TM 100 - American International Chemical Thimerosal USP 97% (bulk chemical) TM 97 - American Pharmaceutical 12 Hour Nasal Solution PMA NS - Appletree Markets Long Lasting Nasal Spray PMA NS * Bausch & Lomb...
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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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THE MERCK MANUAL, Sec. 5, Ch. 55, Crystal-Induced Conditions
This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 5
Crystal-In duced Conditions Topics Gout Idiopathic Hyperuricemia Calcium Pyrophosphate Dihydrate Crystal Deposition Disease Basic Calcium Phosphate And Other Crystal Disorders Gout A recurrent acute or chronic arthritis of peripheral joints that results from deposition in and about the...
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
SOTALOL HCL AS MFG & SOLD UNDER THE SIEGFRIED LABEL 3724 21-Feb-80 AVENTIS PHARMA SA "1,A,24-DIHYDROXYCHOLECALCIFEROL" 3725 07-Feb-80 DINAMITE DIPHARMA SPA ISOSORBIDE DINITRATE (ISDN) 3743 10-Mar-80 MEDI PHYSICS INC "CYCLOTRON OPERATION, INDIUM CL (IN 111)MANUFACTURED IN EMERYVILLE, CALIFORNIA." 3746 10-Mar-80 MEDI PHYSICS INC "CYCLOTRON OPERATION, THALLOUS CL (TL-201), NORTH...
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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 BV,...
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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
- INJECTION Approved 8/13/2003- ESTROPIPATE 1.2 mg - 02P-0141/CP1 WOMEN FIRST HEALTHCARE - TABLETS Approved 9/24/2002- ETHINYL ESTRADIOL 0.035 MG NORETHINDRONE 0.4 MG - 99P-1150/CP1 KIRKLAND & ELLIS - TABLET; CHEWABLE Approved 4/14/2000- FAMOTIDINE 10MG - 00P-1422/CP1 YAMANOUCHI PHARMA TECHNOLOGIES - TABLET; ORALLY DISINTEGRATING Approved 4/17/2001- FENOFIBRATE 107 mg - 02P-0148/CP1...
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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 >D> AB WYETH...
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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First-Time Generics - December 2000
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - December 2000 NAME Approval DATE PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION, 15 MG (BASE)/5 ML 12/14/00 DOXYCYCLINE TABLETS, 50 MG, 100 MG 12/15/00 CARBAMAZEPINE ORAL SUSPENSION USP, 100 MG/5 ML 12/21/00 Back to Top - Back to Approvals FDA/Center for...
author: USERNAME
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ANDA Tentative Approvals - January 2002
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - January 2002 - ANDA Number Drug Name Applicant Tentative Approval Date 1 76-007 LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG RANBAXY LABORATORIES LIMITED 1/4/02 2 76-113 LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG...
author: USERNAME
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CDER Template - Replace Title Here
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - June 2002 - Generic Drug Name Generic Manufacturer Brand Name Approval Date- 1- AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, U 200 MG/28.5 MG (BASE)/5 ML, AND 400 MG/57 MG (BASE)/5 ML GENEVA PHARMACEUTICALS, INC
AUGMENTIN 200 MG/5 ML AND AUGMENTIN...
author: USERNAME
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ANDA Approvals June 2002
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - June 2002 - ANDA Number Drug Name Applicant Approval Date 1 65-066 AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, U 200 MG/28.5 MG (BASE)/5 ML, AND 400 MG/57 MG (BASE)/5 ML GENEVA PHARMACEUTICALS, INC
6/5/02 3 75-991 LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND...
author: OGD
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CDER Template - Replace Title Here
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - July 2002 - ANDA Number Drug Name Applicant Approval Date 1 75-743 LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG PAR PHARMACEUTICAL, INC
7/1/02 3 75-776 LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/ 25 MG IVAX...
author: USERNAME
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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...
author: OGD
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First-Time Generics - December 2002
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - December 2002 - Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 AMANTADINE HYDROCHLORIDE TABLETS 100 MG UPSHER-SMITH LABORATORIES, INC
SYMMETREL TABLETS 12/16/02 2 DILTIAZEM HYDROCHLORIDE FOR INJECTION 100 MG ADD-VANTAGE VIALS ABBOTT...
author: OGD
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ANDA Approvals December 2002
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - December 2002 - ANDA- Number Generic Drug Name Applicant Approval Date 1 65-116 BACITRACIN FOR INJECTION, USP 50,000 UNITS/VIAL AMERICAN PHARMACEUTICAL PARTNERS, INC
12/16/02 6 76-186 AMANTADINE HYDROCHLORIDE TABLETS 100 MG UPSHER-SMITH LABORATORIES, INC
12/16/02 7 76...
author: OGD
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