NUMERICAL INDEX NUMERICAL INDEX 000455 see Thyroid Panel 000620 see Thyroid Panel With TSH 000679 see Hemoglobinopathy Profile 000703 see Renin Activity and Aldosterone 000810 see Vitamin B12 and Folates 001016 see Calcium, Serum 001024 see Phosphorus, Serum 001032 see Glucose, Serum 001040 see Urea Nitrogen, Serum 001057 see Uric Acid, Serum 001065 see Cholesterol, Total 001073 see Protein, Total,...
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...
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...
1996 and Older - New Drug Application (NDA) New Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
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 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN...
1997 Warning Letters and Notice of Violation Letters to Pharmaceutical Companies Food and Drug Administration • Center for Drug Evaluation and Research Compliance Activities Search Warning Letters and Untitled Letters to Pharmaceutical Companies 1997 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 82 5032 05-Aug-83 KNOLL AG LUDWIGSHAFEN "CAFFEINE (HYDROUS, ANHYDROUS FORMS)" 5033 19-May-83 DEGUSSA AG L-ARGININE ACETATE AS PRODUCED BY REXIM S.A.DIV DEGUSSA -HAM FRANCE 5038 15-Aug-83 JOHNSON MATTHEY PLC "BULK FENTANYL CITRATE MANUFCAFFEINE AS MFG
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls AVENTIS PHARMA SA HYDROCORTISONE HEMISUCCINATE ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV ERTHROMYCIN PHOSPHATE ORGAMOL SA BUPIVACAINE HCL AVENTIS PHARMA SA 6-ALPHA-METHYLPREDNISOLONE HEMISUCCINATE PROCOS SPA PHENYLTOLOXAMINE CITRATE PROCOS SPA ORPHENADRINE HYROCHLORIDE & ORPHENADRINE CITRATE BASF CORP POVIDONE-IODINE LEK PHARMACEUTICALS D.D
Prescription and Over-the-Counter Drug Product List: 8/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> AB VINTAGE PHARMS 325MG;50MG;40MG N40511 001 AUG 27, 2003 AUG NEWA >A> AB 500MG;50MG;40MG N40513 001 AUG 25, 2003 AUG NEWA ESGIC-PLUS >D> AB + MIKART 500MG;50MG;40MG N89451 001 MAY 23, 1988 AUG CTNA >A> AB + 500MG;50MG;40MG...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 6/2003 4 >D> + ROBINS AH 325MG;60MG N84446 001 JUN DISC >A> @ 325MG;60MG N84446 001 JUN DISC ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE; ORAL DIAMOX >A> @ DURAMED PHARM BARR 500MG N12945 001 JUN CAHN >A> + 500MG N12945 003 APR 25, 1995 JUN CAHN >D> @ LEDERLE 500MG N12945 001 JUN CAHN >D> + 500MG N12945 003 APR 25, 1995 JUN CAHN TABLET; ORAL >A> AB DURAMED PHARM BARR 125MG N08943 001 JUN CAHN ...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 4/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL FIORICET -D- AB + NOVARTIS 325MG;50MG;40MG N88616 001 NOV 09, 1984 APR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG N88616 001 NOV 09, 1984 APR CAHN ACYCLOVIR CAPSULE; ORAL ACYCLOVIR -A- AB AAIPHARMA 200MG N74833 001 APR 22, 1997 APR CAHN -D- AB AESGEN 200MG N74833 001 APR 22,...
author: AUTHOR
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...
author: AUTHOR
http://www.repromed.com.au/DOCUMENTS/statement.pdf Information Statement Table of Contents i Welcome to 1 Out of Hours Contact 1 Legal Aspe 2 Health and 4 Counselling and Support 5 Medications 6 Ovulation 8 Intra Uterine Insemination 10 Donor Sperm Program (DI) 12 IVF, ICSI Treatment 13 § How many eggs to be Inseminated
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 OfficeCaffeine and Dihydrocodeine Bitartrate capsules 356.4mg/30mg/16mg [2 MB] Mikart, Inc
FDA Drug Approvals List November 2001 - Drug Approvals for November 2001 Definitions and Notes Original New Drug Applications Original Application #: 021277 Approval Date: 30-NOV-01 Trade Name: AVELOX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: BAYER CORP PHARMACEUTICAL DIV Active Ingredient(s): MOXIFLOXACIN HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the treatment of adults ...
FDA Drug Approvals List August 2001 Active Ingredient(s): PREDNISONE OTC/RX Status: RX Original Abbreviated Application # 075733 Approval Date: 22-AUG-01 Trade Name: CLOBETASOL PROPIONATE Dosage Form: EMULSION, CREAM Applicant: STIEFEL LABORATORIES INC Active Ingredient(s): CLOBETASOL PROPIONATE OTC/RX Status: RX Original Abbreviated Application # 074911 Approval Date: 22-AUG-01 Trade Name: PHRENILIN Dosage Form:...
FDA Drug Approvals List July 2002 45 Dosage Form: INJECTABLE Applicant: XCEL PHARMACEUTICALS Active Ingredient(s): DIHYDROERGOTAMINE MESYLATE OTC/RX Status: RX Application #: 020449 Labeling Supplement #: 019 To Original New Drug Application Approval Date: 30-JUL-02 Trade Name: TAXOTERE Dosage Form: INJECTABLE Applicant: AVENTIS PHARMACEUTICALS INC Active Ingredient(s): DOCETAXEL OTC/RX Status: RX Application #:...
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...
FDA Drug Approvals List February 2002 Active Ingredient(s): BUSPIRONE HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application#065022 Approval Date: 27-FEB-02 Trade Name: BACITRACIN ZINC AND POLYMYXIN B SULFATE Dosage Form: OINTMENT Applicant: ALTANA INC Active Ingredient(s): BACITRACIN ZINC; POLYMYXIN B SULFATE OTC/RX Status: RX Original Abbreviated Application# 075874 Approval Date: 26-FEB-02 Trade...
LIST OF APPROVED DRUGS FOR WHICH ADDITIONAL PEDIATRIC INFORMATION DOCKET NOCaffeine Treatment of pain associated with migraine headache
Prescription and OTC Drug Product List 12/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE CAPSULE; ORAL SYNALGOS-DC-A -A- @ WOMEN FIRST HLTHCARE 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN -D- @ WYETH AYERST 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL ANEXSIA 5/325 -D- AA MALLINCKRODT 325MG;5MG...
Prescription and OTC Drug Product List 7/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE -A- AB ABLE 325MG;50MG;40MG N40390 001 JUL 23, 2001 JUL NEWA -A- AB 500MG;50MG;40MG N40394 001 JUL 23, 2001 JUL NEWA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA + WATSON LABS...
Prescription and OTC Drug Product List 6/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA PEACHTREE 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN -A- AA UCB 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE TABLET; ORAL DARVOCET -A- @ AAIPHARMA LLC 325MG;32.5MG N16844 001 JUN CAHN -D- @...
Published in FEDERAL REGISTER in 2000 (Volume 65) Index of Significant OTC Drug Federal Register Publications 1990 – 2003 (Volumes 55 – 68) Updated April 2003 Division of Over- the- Counter Drug Products Office of Drug Evaluation V Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane (HFD- 560) Rockville, MD 20850 Index of Significant OTC Drug Federal Register Publications Page 1 Table of...
author: CDER USER
duplicates:http://www.fda.gov/cder/Offices/OTC/significant_publications_6-13-2003.pdf
