http://www.fda.gov/cder/orange/appendix_a.txt ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
Microsoft Word - WMA46910.DOC 7348729 HYDROCORTONE ® Acetate INJECTABLE SUSPENSION (HYDROCORTISONE ACETATE) (Formerly called STERILE SUSPENSION HYDROCORTONEa Acetate) For intra- articular, intralesional, and soft tissue injection only
duplicates:http://www.merck.com/product/usa/pi_circulars/h/hydrocortone/hydrocortone_acesus_pi.pdf
Microsoft Word - WMA46910.DOC page 6
duplicates:http://www.merck.com/product/usa/pi_circulars/h/hydrocortone/hydrocortone_acesus_pi.pdf
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, GANTANOL to LYSODREN Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS GANTANOL to LYSODREN Trade Name Generic GANTANOL Sulfamethoxazole GANTRISIN Sulfisoxazole GARAMYCIN Gentamicin GEOCILLIN Carbenicillin GLUCOPHAGE Metformin GLUCOTROL Glipizide GRIFULVIN V Griseofulvin GRISACTIN Griseofulvin HALCION Triazolam HALDOL Haloperidol HALDRONE Paramethasone HALOTESTIN...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Paclitaxel to Rosiglitazone Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Paclitaxel to Rosiglitazone Generic Trade Name Paclitaxel TAXOL Pamidronate AREDIA Pancrelipase PANCREASE, VIOKASE Pancuronium PAVULON Papaverine PAVABID Paramethadione PARADIONE Paramethasone HALDRONE Pargyline EUTONYL Paromomycin HUMATIN Paroxetine PAXIL Penbutolol LEVATOL Penciclovir DENAVIR...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, GANTANOL to LYSODREN Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS GANTANOL to LYSODREN Trade Name Generic GANTANOL Sulfamethoxazole GANTRISIN Sulfisoxazole GARAMYCIN Gentamicin GEOCILLIN Carbenicillin GLUCOPHAGE Metformin GLUCOTROL Glipizide GRIFULVIN V Griseofulvin GRISACTIN Griseofulvin HALCION Triazolam HALDOL Haloperidol HALDRONE Paramethasone HALOTESTIN...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Paclitaxel to Rosiglitazone Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Paclitaxel to Rosiglitazone Generic Trade Name Paclitaxel TAXOL Pamidronate AREDIA Pancrelipase PANCREASE, VIOKASE Pancuronium PAVULON Papaverine PAVABID Paramethadione PARADIONE Paramethasone HALDRONE Pargyline EUTONYL Paromomycin HUMATIN Paroxetine PAXIL Penbutolol LEVATOL Penciclovir DENAVIR...
THE MERCK MANUAL, Sec. 5, Ch. 55, Crystal-Induced Conditions This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 5.Phosphate And Other Crystal Disorde rs Gout A recurrent acute or chronic arthritis of peripheral joints that results from deposition in and about the...
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.
http://www.merck.com/product/usa/pi_circulars/d/decadron/decadron_tblts_pi.pdf page 7
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...
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...
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...
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...
THE MERCK MANUAL, Sec. 5, Ch. 55, Crystal-Induced Conditions This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 5Phosphate And Other Crystal Disorders Gout A recurrent acute or chronic arthritis of peripheral joints that results from deposition in and about the...
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...
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,...
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...
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...
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
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
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
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
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
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
