http://www.fda.gov/cder/orange/appendix_a.txt 2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO, SECRETIN...
DDPA January 1996 74-467 RANITIDINE GENEVA PHARM RANITIDINE 31-JAN-96 (TABLET) BRO OMFIELD, CO 150MG 80038 300MG (HISTAMINE H-2 RECEPTOR ANTAGONIST) 74-475 TERFENADINE BAKER NORTON TERFENADINE 31-JAN-96 (TABLET) MIAMI, FL 60MG 33178 (ANTIHISTAMINE) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 20-280 GENOTROPIN PHARMACIA SOMATROPIN, BIOSYNTHETIC 20-DEC-95 (INJECTABLE) COLUMBUS, OH 5.8MG/VIAL 43216 ...
LIST OF APPROVED DRUGS FOR WHICH ADDITIONAL PEDIATRIC INFORMATION DOCKET NOCalcium acetate For treatment of hyperphosphatemia in end stage renal failure patients
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 25 Iu Somatropin Pituitary & Recombinant 0.20 ru Soybean Oil Emulsion 3.13 mL Spectinomycin HCl 57.00 mg Streptokinase 21428.00 IU Streptokinase- Streptodornase (Local) Streptokinase- Streptodornase 0 Streptomycin Sulfate Streptozocin Succinylcholine Chloride Sufentanil citrate Invert Sugar Invert Sugar in Sodium Chloride Sulbactam Sodium Sulfadiazine Sodium Sulfamethoxazole &...
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 Conc.( equine) 3.00 mL Dipyridamole 0.14 mg Dobutamine HCI 0.90 mg 5.00 1.10 2.17 3.57 1.80 1.80 1.80 1.80 45.45 5.00 1.25 5.56 11.60 + 0.50 + 35.70 + 71.43 16.70 + 17.20 + 0.70 + 0.70 + 111.00 + 200.00 + 1.00 357.00 0.003 + 0.50 + 166.67 1.00 4.00 0.50 + 1.00 8.77 3.40 + 16.67 1.67 37.70 5.56 40 Dopamine HCI Dopamine HCl in Dextrose Doxapram HCI Injection Doxorubicin HCI for...
author: FDA / CBER
subject: December 1987 Guideline
QUESTION NO - - QUESTION NO.- 1120385.004 DRUG DELIVERY Citation Information Copyright 2001 NERAC Inccalcium silicate, magnesium silicate, aluminum silicate, or mixtures thereof
may20lst.PDF 98N- 0056 May 20, 1998 Page 11 Drug Name Potential pediatric use limited to approved indications Age Group In Which More Information Needed birth to 1 mos 1 mos to 2 yrs 2 to 12 years 12 to 16 years Technetium Tc- 99m Mebrofenin Radioactive diagnostic for hepatobiliary imaging Yes Yes Yes Yes Technetium Tc- 99m Medronate Bone imaging agent to delineate areas of altered osteogenesis...
author: Unknown
FDA DRUG AND DEVICE PRODUCT APPROVALS 74-776 TIMOLOL MALEATE BAUSCH AND LOMB TIMOLOL MALEATE 26-JUL-96 (SOLUTION/DROPS) TAMPA, FL 0.5% 33637 (BETA ADRENERGIC BLOCKER) 74-778 TIMOLOL MALEATE BAUSCH AND LOMB TIMOLOL MALEATE 26-JUL-96 (SOLUTION/DROPS) TAMPA, FL 0.25% 33637 (BETA ADRENERGIC BLOCKER) 74-465 TIMOLOL MALEATE ADV REMEDIES TIMOLOL MALEATE 30-JUL-96 (SOLUTION/DROPS) SOMERSET, NJ 0.25% 08873 (BETA ADRENERGIC...
Therapeutic Biological Approvals FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Therapeutic Biological Approvals - Tradename/ Proper Name Indication for Use STN Manufacturer/ License No
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 developed
CBER - 1996 Biological License Application Approvals FDA Home Page | CBER A-Z Index | CBER Search | Contact CBER | CBER Home Page 1996 Biological License Application Approvals This list reflects information regarding the applications as of the approval date
author: CBER / FDA
chrmscat.p65 page 1
author: cxm9300
NDA Supplement Approval - Indium IN-111 Chloride Sterile Solution, Mallinkrodt FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Product Approval Information - New Drug Application Product name: Indium In-111 Chloride Solution Manufacturer: Mallinckrodt, Inc, StPentetate (Myoscint)...
NDA Supplement Approval- Indium IN-111 Chloride Sterile Solution, Medi-Physics FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Product Approval Information - New Drug Application Product name: Indium In-111 Chloride Solution (Indiclor) Manufacturer: Medi-Physics, Inc d.b.a
Unknown I M& NT" the Fab Iragmenl Iwalites IO Ihe necrotic myocardium lo a grealer degree and is cleared more rapidly lrom the cndalion Circulating radlolabefed MYOSCINT (Imciromab Penlefate) does not have access lo inlraceflular myosin in alu and does nol localize in normal myocardial tissue
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Unknown 6 Table 2 SELECTED PERFORMANCE CHARACTERISTICS OF INDIUM IN 111 IMCIROMAB PENTETATE BASED ON FINAL CLINICAL DIAGNOSIS AND FINAL IMAGE INTERPRETATION" DEFINITIVE DIAGNOSIS Acute mvocardial infarction Estimate 95% Confidence interval Positive (+) cardiac localization of lmciromab Pentetate (" sensitivity") l In patients with diagnostic images only 3161378 = 84% (79%, 87%) l...
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