http://www.fda.gov/cder/orange/appendix_a.txt 12, CHLORPHENIRAMINE MALEATE (OTC) CODOXY, ASPIRIN CODRIX, ACETAMINOPHEN COGENTIN, BENZTROPINE MESYLATE COGNEX, TACRINE HYDROCHLORIDE COL-PROBENECID, COLCHICINE COLAZAL, BALSALAZIDE DISODIUM COLBENEMID, COLCHICINE COLD CAPSULE IV, CHLORPHENIRAMINE MALEATE (OTC) COLD CAPSULE V, CHLORPHENIRAMINE MALEATE (OTC) COLESTID, COLESTIPOL HYDROCHLORIDE COLGATE TOTAL, SODIUM FLUORIDE (OTC) ...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt OF IRELAND" 13266 05-Oct-98 FABBRICA ITALIANA SINTETICI SPA "NITROFURANTOIN MONHYDRATE, MANUFACTURED IN VICENZA, ITALY" 13277 22-Oct-98 MATRIX LABORATORIES LIMITED "ACYCLOVIR USP, MANUFACTURED IN ANDHRA PRADESH, INDIA" 13279 19-Oct-98 SYLACHIM DIV FINORGA "LEVOBETAXOLOL HYDROCHLORIDE, MANUFACTURED IN CHASSE-SUR-RHONE, FRANCE" 13282 15-Oct-98 DAICEL CHEMICAL INDUSTRIES LTD "CHIRALPAK...
RLD_LABELING_APPROVED_NOV_1999 Firm Date AMINOHIPPURATE Na Na Aminohippurate 5-619 S-015 Merck 2-Nov-1999 FLOLAN Epoprostenol Na Injection 20-444 S-004 Glaxo Wellcome 2-Nov-1999 DEXEDRINE Dextroamphetamine SO4 ER Capsules 17-078 S-034 SmithKline Beecham 3-Nov-1999 ZOLADEX Goserelin Acetate Implant 20-578 S-009 Zeneca 3-Nov-1999 ZOLADEX Goserelin Acetate Implant 3.6 Mg 19-726 S-030 Zeneca 3-Nov-1999 CERVIDIL...
http://www.adis.com/files/newsletters/INP/ICOV1376.PDF CANCER Cisplatin + gemcitabine for recurrent ovarian cancer 14 Etoposide + ifosfamide beneficial in Ewing's sarcoma 9 Gastrin 17 vaccine gets FDA fast track status 18 Gemcitabine + cisplatin for recurrent ovarian cancer 14 Ifosfamide + etoposide beneficial in Ewing's sarcoma 9 p53 gene therapy product gets FDA orphan drug status 18 Tamoxi f en: generic approvals in the US 18...
Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices at 56- 57oC) 3.00 mL Antirabies Serum 3.00 mL Antitoxin (Gas Gangrene) 3.00 mL Antivenom 3.00 mL Apommorphine HCl Tablets for Injection 0.09 mg Arginine HCl Injection 500.00 mg Ascorbic Acid 4.20 mg Asparaginase for Injection 1000.00 Iu Atracurium Besylate 0.50 mg Atropine Sulfate 0.09 mg Aurothioglucose Suspension 0.70 mg Azathioprine Sodium for Injection 5.00 mg Azlocillin 75.00 mg...
author: FDA / CBER
subject: December 1987 Guideline
Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices page 5
author: FDA / CBER
subject: December 1987 Guideline
2PenCont4-30402.doc Methods for sample preparation Type of sample Amphotericin B bulk Amphotericin B for injection Bacitracin and zinc bacitracin bulk and tablets, sterile bacitracin Candicidin bulk Capreomycin sulfate bulk Chloramphenicol bulk, capsules Chloramphenicol palmitate bulk, oral suspension Clindamycin HCl hydrate bulk, capsules Colistimethate sodium bulk Colistin sulfate bulk, powder...
author: WINTHROPS
2PenCont4-30402.doc page 14
author: WINTHROPS
http://www.fda.gov/cder/fdama/fedreg/01242000.txt Almecillin Amdinocillin Amikacin Amoxicillin Amphomycin Amphotericin B Ampicillin Azacitidine Azaserine Azithromycin Azlocillin Aztreonam Bacampicillin Bacitracin Benzyl penicilloyl-polylysine Bleomycin Candicidin Capreomycin Carbenicillin Cefaclor Cefadroxil Cefamandole Cefazolin Cefdinir Cefepime Cefixime Cefmenoxime Cefmetazole Cefodizime Cefonicid Cefoperazone Ceforanide...
FDA Drug Approvals List- February 1999 Applicant: CONNETICS CORP Active Ingredient(s): BETAMETHASONE VALERATE OTC/RX Status: RX Indication(s):For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp Original Application #: 020969 Approval Date: 25-FEB-99 Trade Name: UVADEX Chemical Type: 3 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: THERAKOS INC...
Document 15 / Monday, January 24, 2000 / Proposed Rules Cloxacillin Colistimethate Colistin Cyclacillin Cycloserine Cyclosporine Dactinomycin Dalfopristin Daunorubicin Demeclocycline Detorubicin Dicloxacillin Dihydrostreptomycin Dirithromycin Doxorubicin Doxycycline Epirubicin Erythromycin Floxacillin Fosfomycin Fusidate/ fusidic acid Gentamicin Gramicidin Griseofulvin Hetacillin...
author: U.S. Government Printing Office
subject: Extracted Pages
Document page 5
author: U.S. Government Printing Office
subject: Extracted Pages
http://www.fda.gov/cder/ogd/rld/50108s21.pdf page 6
http://www.fda.gov/cder/ogd/rld/50108s21.pdf page 5
http://www.fda.gov/cder/ogd/rld/50108s21.pdf page 4
FDA Drug Approvals List November 1999 Approvable Original New Drug Applications Original Application #: 020125 Approvable Date: 30-NOV-99 Trade Name: ACCURETIC Dosage Form: TABLET Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO Active Ingredient(s): QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE OTC/RX Status: RX Original Abbreviated Application #: 075366 Tentative Approval Date: 02-NOV-99 Trade Name:...
H: 16AP.PDF ANDA 64- 216 February 26, 1999 Pharma- Tek, IncColistimethate for Injection USP, 150 mg (base)/ vial
author: Unknown
H: 16AP.PDF page 1
author: Unknown
