Drug Approvals - B Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Bacitracin Injection, 50,000 units/vial, Rx American Pharmaceutical Partners ANDA 65-116 12/3/02 - - - Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, Rx Altana, IncBicillin CR...
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,...
FDA Drug Approvals List April 2002 - Drug Approvals for April 2002 Definitions and Notes Original New Drug Applications Original Application #: 021310 Approval Date: 05-APR-02 Trade Name: ALORA Chemical Type: 3 Therapeutic Potential: S Dosage Form: PATCH, CONTROLLED RELEASE Applicant: WATSON LABORATORIES INC Active Ingredient(s): ESTRADIOL OTC/RX Status: RX Indication(s): For the prevention of postmenopausal...
C:\Data\My Documents\50138.ap.4sup.42602.DOC DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 NDA 50- 138/ S- 222 NDA 50- 138/ S- 223 NDA 50- 141/ S- 218 NDA 50- 141/ S- 219 King Pharmaceuticals, Inc
author: Susmita Samanta
C:\Data\My Documents\50138.ap.4sup.42602.DOC page 1
author: Susmita Samanta
UK 9250-7.pdf Bicillin ® L- A (penicillin G benza hine injec able suspension) TUBE ® 1 mL and 2 mL for deep IM injec ion only only DESCRIPTION Bicillin L- A ( penicillin G benza hine injec able suspension) is available for deep in ramuscular injec ionBicillin L- A con ains penicillin G benza...
author: gracej
UK 9250-7.pdf page 3
author: gracej
UK 9250-7.pdf page 1
author: gracej
Medicines, Ethics and Practice page 5
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, ABBOKINASE to BUTAZOLIDIN Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS ABBOKINASE to BUTAZOLIDIN Trade Name Generic ABBOKINASE Urokinase ACCOLATE Zafirlukast ACCUPRIL Quinapril ACCUTANE Isotretinoin ACHROM YCIN V Tetracycline ACTHAR Corticotropin (ACTH) ACTIFED *Triprolidine ADALAT Nifedipine ADENOCARD Adenosine ADRIAMYCIN Doxorubicin ADVIL Ibuprofen AFRIN...
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...
Specificity Table TOX.xls Tested (ng/ ml) BAL Dimercaprol Chelating agent 100,000 Barbitone Barbital Barbiturate 100,000 BAR 150 Baycol Cerivastatin Antihyperlipidemic 10,000 BDB BDB( d, l- 1-( 3,4- Methylenedioxyphenyl)- 2- Butanamine) MBDB metabolite 100,000 AMP 2,500 Benadryl Diphenhydramine Antihistamine/ Sedative 1,000,000 Benemid Probenecid Antigout 100,000 Bentyl Dicyclomine Anticholinergic 100,000...
author: Biosite Incorporated
Specificity Table TOX.xls page 4
author: Biosite Incorporated
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, ABBOKINASE to BUTAZOLIDIN Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS ABBOKINASE to BUTAZOLIDIN Trade Name Generic ABBOKINASE Urokinase ACCOLATE Zafirlukast ACCUPRIL Quinapril ACCUTANE Isotretinoin ACHROMYCIN V Tetracycline ACTHAR Corticotropin (ACTH) ACTIFED *Triprolidine ADALAT Nifedipine ADENOCARD Adenosine ADRIAMYCIN Doxorubicin ADVIL Ibuprofen AFRIN...
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...
Reference Listed Drug Labeling Approved in April 2002 letter --- erythromycin ethylsuccinate tablet 50-297 SLR 019 ERYPED letter --- erythromycin ethylsuccinate oral susp 50-207 SLR 057 PCE letter --- erythromycin ethylsuccinate tablet 50-611 SLR 019 Apr 26 TAMIFLU letter label oseltamivir phosphate capsule 21-087 SLR 010 TAMIFLU letter label oseltamivir phosphate oral susp 21-246 SLR 007 Apr 29 TIMOPTIC letter label timolol maleate...
author: USERNAME
Reference Listed Drug Labeling Approved in March 2002 Approval Date Product Name Active Ingredient(s) Dosage Form NDA No Supp No Mar 1 BICILLIN C-R letter - penicillin G benzathine/ procaine injection 50-138 S-219 - BICILLIN L-A letter - penicillin G benzathine/ procaine injection 50-141 S-215 - COLY-MYCIN S letter - colistin & neomycin sulfates/thonzonium Br /hydrocortisone acetate otic suspension 50...
author: USERNAME
C:\Data\My Documents\50141.215.ap.22702.doc page 1
author: Susmita Samanta
C:\Data\My Documents\50138.s219.ap.22702.doc page 1
author: Susmita Samanta
UK 9250-7.pdf page 2
author: gracej
THE MERCK MANUAL, Sec. 13, Ch. 164, Sexually Transmitted Diseases Treatment Penicillin is the antibiotic of choice for all stages of syphilis.Benzathine penicillin G 2.4 million U IM once produces a satisfactory blood level for 2 wk (usually, 1.2 million U is given in each buttock).penicillin G 600,000 U/day IM for 10 days may be given but offers no advantage.Penicillin ...
THE MERCK MANUAL, Sec. 13, Ch. 153, Antibacterial Drugs Antibacterial Drugs Topics [General] -Lactam Antibiotics Aminoglycosides Macrolides, Lincomycin, And Clindamycin Tetracyclines Miscellaneous Antibiotics Quinolones Polypeptides < TR> Sulfonamides Trimethoprim-Sulfamethoxazole Antimicrobial Chemoprophylaxis -Lactam Antibiotics PENICILLINS Penicillin G -like drugs Penicillin G Penicillin V Procaine...
THE MERCK MANUAL, Sec. 13, Ch. 157, Bacterial Diseases Treatment Benzathine penicillin G 1.2 million U IM (a single 600,000-U dose in each buttock) or erythromycin 0.5 g qid po for 7 days cures erysipeloid.penicillin G 25,000 to 30,000 U/kg IV q 4 h or cefazolin 15 to 20 mg/kg IV q 6 h.penicillin G ...
THE MERCK MANUAL, Sec. 19, Ch. 270, Musculoskeletal And Connective Tissue Disorders This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 19.
THE MERCK MANUAL, Sec. 13, Ch. 164, Sexually Transmitted Diseases Treatment Penicillin is the antibiotic of choice for all stages of syphilisBenzathine penicillin G 2.4 million U IM once produces a satisfactory blood level for 2 wk (usually, 1.2 million U is given in each buttock)penicillin G 600,000 U/day IM for 10 days may be given but offers no advantagePenicillin ...
