material_safety_data_sheet_letter_new_.doc ALLERGAN 2525 Dupont Drive, P.
author: hutton_ronald
material_safety_data_sheet_letter_new_.doc page 1
author: hutton_ronald
Baxter s Products & Services Directory page 14
author: Center for One Baxter
subject: For questions about our Products and Services
duplicates:http://www.baxter.com/customers/products_svcs/2003_products_and_services_directory.pdf
Baxter s Products & Services Directory Tablets MESNEX* (MESNA) Product Information: Bristol Myers- Squibb Medical Services 800- 426- 7644 ALFENTANIL HYDROCHLORIDE INJECTION ATIVAN (LORAZEPAM) INJECTION AMIODARONE HYDROCHLORIDE INJECTION ATRACURIUM BESYLATE INJECTION ATROPINE SULFATE INJECTION, USP BUMETANIDE INJECTION BUTORPHANOL TARTRATE INJECTION, USP CISplatin INJECTION DILTIAZEM HCI INJECTION DOBUTAMINE INJECTION, USP...
author: Center for One Baxter
subject: For questions about our Products and Services
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, TACARYL to ZYPREXA Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS TACARYL to ZYPREXA Trade Name Generic TACARYL Methdilazine TACE Chlorotrianisene TAGAMET Cimetidine TALWIN *Pentazocine TAMBOCOR Flecainide TAMIFLU Oseltamivir TAPAZOLE Methimazole TASMAR Tolcapone TAVIST Clemastine TAXOL Paclitaxel TAZICEF Ceftazidime TAZIDIME Ceftazidime TEGISON Etretinate...
Drug Approvals - A This newly approved or tentatively approved drug listing is an interim page intended to provide timely information on new drug products as a more comprehensive page is developedketorolac tromethamine) ophthalmic solution, 0.5% Allergan NDA 19700/S18 7/6/01 - 6/16...
Prescription and Over-the-Counter Drug Product List: 1/2004 ADULT >A> + AAIPHARMA LLC 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL ;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL; 40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/V IAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL N21625 001 JAN 30, 2004 JAN NEWA BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED; TOPICAL BETAMETHASONE DIPROPIONATE >A> AB ATRIX EQ 0.05% BASE N76603 001 JAN 23, 2004 JAN NEWA BUPROPION HYDROCHLORIDE TABLET, EXTENDED...
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 ACETAMINOPHEN,...
Drug Approvals - K ANDA 75-679 2/20/02 4/10/03 Ketoprofen Extended-release capsules, 100 mg, 150 mg and 200 mg Andrx Pharmaceuticals ANDA 75-270 3/24/99 3/29/99 - - Ketorolac Tromethamine Ophthalmic Solution, 5%, Rx Tentatively Approved Novex Pharma ANDA 76-109 5/30/03 - - - Ketorolac Tromethamine Injection USP, 15 mg/mL & 30 mg/mL, Rx American Pharmaceutical Partners ANDA 75...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, TACARYL to ZYPREXA Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS TACARYL to ZYPREXA Trade Name Generic TACARYL Methdilazine TACE Chlorotrianisene TAGAMET Cimetidine TALWIN *Pentazocine TAMBOCOR Flecainide TAMIFLU Oseltamivir TAPAZOLE Methimazole TASMAR Tolcapone TAVIST Clemastine TAXOL Paclitaxel TAZICEF Ceftazidime TAZIDIME Ceftazidime TEGISON Etretinate...
1997 Warning Letters and Notice of Violation Letters to Pharmaceutical Companies Johnson DDMAC 9/24/1997 5/29/1998 Posicor (Mibefradil Dihyrdrochloride) Tablets Hoffman-La Roche DDMAC 9/5/1997 5/29/1998 Salagen (Pilo carpine HCl) MGI Pharma DDMAC 9/24/1997 5/29/1998 Site Inspection Gedeon Richter, Ltd DMPQ 9/5/1997 9/24/1997 Zocor (Simvastatin) Merck DDMAC 9/22/1997 5/29/1998 October 1997 Accolate (Zafirkulast) Tablets Zeneca Pharmaceuticals DDMAC 10/1/1997 5/22...
1998 Warning Letters and Untitled Letters to Pharmaceutical Companies DDMAC 6/25 6/29 Maxipime (Cefepime HCl) for Injection Bristol-Myers Squibb DDMAC 6/29 8/3 Mircette (Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol) Tablets Organon DDMAC 6/1 6/9 Naprelan (Naproxen Sodium) Tablets Wyeth-Ayerst DDMAC 6/8 6/29 Nasacort (Triamcinolone Acetonide) Rhone-Poulenc Rorer DDMAC 6/25 6/29 Nasonex (mometasone furoate monohydrate) nasal spray Schering...
Maximum Recommended Therapeutic Dose (MRTD) Database Maximum Recommended Therapeutic Dose (MRTD) Database (1,235 pharmaceuticals) A -- B- - C -- D -- E -- F-G -- H-K -- L -- M -- N -- O -- P -- Q-R -- S -- T -- U-Z MRTD--- (mg/kg--- bw/day) -- Generic Chemical Name Chemical Structure (SMILES Code) 3.00000-- Acemetacin C1=C(OC)C=C3C(=C1)N(C(=O)C2=CC=C(Cl)C=C2)C(C)=C3CC(=O)OCC(O)=O 0.20000-- Acenocoumarol C1=CC=C3C(=C1)OC(=O)C(C(CC(C)=O...
NDA Approvals for Calendar Year 2003 NDA APPROVALS FOR CALENDAR YEAR 2003 Updated through December 31, 2003 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21434 Xanax XR Alprazolam Pharmacia and Upjohn FR 3 S 17-Jan-03 21305 Sodium Iodide I-131 Sodium Iodide I-131 DraxImage 3,5 S 24-Jan-03 20414 Pyridostigmine Bromide Pyridostigmine Bromide US Army 3 P 05-Feb-03...
author: Susan Daugherty
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt LISINOPRIL CRUDE AS MFG IN COURBEVOIE AND HAM FRANCE 14537 19-Nov-99 FUJISAWA PHARMACEUTICAL CO LTD FK8453 DRUG SUBSTANCE AS MFG IN HYOGO AND OSAKA JAPAN 14538 09-Nov-99 SICOR DE MEXICO SA DE CV AMCINONIDE AS MFG IN LERMA MEXICO 14539 18-Nov-99 "UQUIFA ITALIA, S.P.A." CLINDAMYCIN HYDROCHLORIDE USP AS MFG IN MILAN ITALY 14540 18-Nov-99 DIOSYNTH BV TESTOSTERONE UNDECANOATE AS MFG IN...
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 FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -OGD Suitability Tracking Report (Sorted by Drug Name) as of 1/5/2004 Drug/Strength Petition No/Firm Dosage Form Status Status Date ACETAMINOPHEN 200MG;200MG; 200MG HYDROCODONE BITARTRATE 5MG;7.5MG;10MG - 02P-0004/CP1 SHOTWELL AND CARR, INC
Prescription and Over-the-Counter Drug Product List: 10/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA VINTAGE PHARMS 500MG/15ML;7.5MG/15ML N40520 001 OCT 30, 2003 OCT NEWA TABLET; ORAL ANEXSIA >D> AA MALLINCKRODT 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA >A> AA 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA ALBUTEROL SULFATE TABLET...
Generic Tentative Approvals - May 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - May 2003 - ANDA Number Generic Drug Name Applicant Tentative Approval Date 1 76-386 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG RANBAXY LABORATORIES LIMITED 5/2/2003- 2 76-424 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG PLIVA, INC
author: OGD
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
74754_ketorolac.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Ketorolac Tromethamine Tablets USP Company:-- Lemmon Company Application No.:--74-754 Approval Date:- 5/16 /1997 - Approval Letter(s) - Printed Labeling - Chemistry Review(s) -- Bioequivalence Review(s) - Administrative Document(s) - Correspondence - - Back to Drug Approval...
author: Paul Stauffer
ANDAs Approvals - November 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals-November 2000 Page: 1 1
author: USERNAME
First-Time Generics -July 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - July 2001 - Approval Date Drug Name ANDA Number Supplement Number 7/3/01 CROMOLYN SODIUM NASAL SOLUTION, USP 5.2 MG DELIVERED/SPRAY, (40 MG/ML), 26 ML BOTTLEKETOROLAC TROMETHAMINE INJECTION, USP 30 MG/ML (MULTIPLE-DOSE VIALS) 75...
author: USERNAME
Drug Approval Package FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Acular LS (Ketorolac Tromethamine) Ophthalmic Solution Company:- Allergan Inc
