Drug Approvals - D
Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted DMSA (Kit for the preparation of Tc99m Succimer for Injection), Rx Amersham Health NDA 17-944/S-018 11/24/03 11/25/03 - - Dacarbazine for Injection USP, 200 mg/vial, Rx Faulding Pharmaceutical Co Delestrogen (estradiol valerate) Injection, USP King Pharmaceuticals NDA 9-402/S37 & S39 12/12/03...
http://www.fda.gov/cder/orange/appendix_a.txt
45, DIHYDROERGOTAMINE MESYLATE DACARBAZINE, DACARBAZINE DALGAN, DEZOCINE DALMANE, FLURAZEPAM HYDROCHLORIDE DANAZOL, DANAZOL DANOCRINE, DANAZOL DANTRIUM, DANTROLENE SODIUM DAPSONE, DAPSONE DARANIDE, DICHLORPHENAMIDE DARAPRIM, PYRIMETHAMINE DARBID, ISOPROPAMIDE IODIDE DARICON, OXYPHENCYCLIMINE HYDROCHLORIDE DARVOCET A500, ACETAMINOPHEN DARVOCET, ACETAMINOPHEN DARVOCET-N 100,...
Reference Listed Drug Labeling Approved in January 2002
Approval Date Product Name Active Ingredient(s) Dosage Form NDA No Supp No Jan 2 CEREBYX letter label fosphenytoin Na injection 20-450 S-007 -- VIAGRA letter label sildenafil citrate tablet 20-895 S-012 Jan 3 FOCALIN letter label dexmethylphenidate HCl tablet 21-278 S-001 --- NARDIL letter label phenelzine sulfate tablet 11-909 S-030 --- TOFRANIL-PM letter label imipramine pamoate...
author: USERNAME
Reference Listed Drug Labeling Approved in February 2001
letter label meropenem for injection 50-706 S-007 SUPRAX letter label cefixime oral suspension 50-622 S-014 VANCOCIN HCL letter label vancomycin hydrochloride capsules 50-606 S-014 ZYVOX letter label linezolid tablets linezolid injection linezolid for oral suspension 21-130 21-131 21-132 S-001 S-001 S-001 Feb 8 AVANDIA letter label rosiglitazone maleate tablets 21-071 S-006...
author: USERNAME
FDA Drug Approvals List February 2001
Approvable Original New Drug Applications - Original Abbreviated New Drug Applications Original Abbreviated Application # 075402 Approval Date: 28-FEB-01 Trade Name: METAPROTERENOL SULFATE Dosage Form: SOLUTION Applicant: NOVEX PHARMA Active Ingredient(s): METAPROTERENOL SULFATE OTC/RX Status: RX Original Abbreviated Application # 075403 Approval Date: 28-FEB-01 Trade Name:...
http://www.fda.gov/cder/foi/appletter/2002/18658s15ltr.pdf page 1
duplicates:http://www.fda.gov/cder/foi/appletter/2002/18658S15LTR.PDF
Marketed Products
Celltech Products ...
A:\18658.14A.doc page 1
author: Babette Merritt
PDPL
- ADD - AB1 0.6MG/HR N89774 001 - DLT - SEARLE 0.35MG N17060 001 - ADD - AUG 30, 1996 - ADD - NOR-QD NITRO-DUR - ADD - + SEARLE 0.35MG N17060 001 - DLT - BX + KEY PHARMS 0.1MG/HR N20145 001 - DLT - APR 04, 1995 - DLT - BX + 0.2MG/HR N20145 002 NYSTATIN - DLT - APR 04, 1995 - DLT - BX + 0.4MG/HR N20145 004 POWDER; TOPICAL - DLT - APR 04, 1995 MYCOSTATIN - DLT - BX + 0.6MG/HR N20145...
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004
- TABLET; ORAL Approved 2/28/2003- BACLOFEN 10 mg, 20 mg - 02P-0078/CP1 KLEINFELD, KAPLAN & BECKER - ORALLY DISINTEGRATING TABLETS Approved 2/5/2003- OXYCODONE 5mg, 7.5mg, 10mg ACETAMINOPHEN 300mg - 02P-0105/CP1 LACHMAN CONSULTANT SERVICES - TABLETS Approved 8/6/2002- CARISOPRODOL 350 mg - 02P-0138/CP1 LACHMAN CONSULTANT SERVICES - ORALLY DISINTEGRATING TABLETS Withdrawn 7/25/2002-...
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004
- SOLUTION; ORAL Approved 4/17/2001- HYDROCODONE POLISTIREX 5 MG, 10 MG CHLORPHENIRAMINE POLISTIREX 4 MG, 8 MG - 03P-0091/CP1 LACHMAN CONSULTANT SERVICES - EXTENDED RELEASE CAPSULES Pending - HYDROCORTISONE ACETATE 2% - 01P-0085/CP1 FERNDALE LABORATORIES INC - CAPSULE; ORAL Withdrawn 7/31/2001- SODIUM TETRADECYL SULFATE 0.5% & 0.2% - 01P-0351/CP1 Bennett and Company -...
Symptoms: Symptoms and Diagnosis of Lung Disorders: Merck Manual Home Edition
Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, DALMANE to FURADANTIN
Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS DALMANE to FURADANTIN Trade Name Generic DALMANE *Flurazepam DANOCRINE Danazol DANTRIUM Dantrolene DARAPRIM Pyrimethamine DARBID Isopropamide DARVON *Propoxyphene DAYPRO Oxaprozin DDAVP Desmopressin DECADRON Dexamethasone DECLOMYCIN Demeclocycline DELALUTIN Hydroxyprogesterone DELATESTRYL...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Dacarbazine to Etretinate
Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Dacarbazine to Etretinate Generic Trade Name Dacarbazine DTIC-DOME Dactinomycin COSMEGEN Danazol DANOCRINE Dantrolene DANTRIUM Daunorubicin CERUBIDINE Deferoxamine DESFERAL Delavirdine RESCRIPTOR Demeclocycline DECLOMYCIN Desipramine NORPRAMIN, PERTOFRANE Desmopressin DDAVP, STIMATE Dexamethasone...
Cold Remedies: Over-the-Counter Drugs: Merck Manual Home Edition
Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
Depression: Depression and Mania: Merck Manual Home Edition
Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, DALMANE to FURADANTIN
Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS DALMANE to FURADANTIN Trade Name Generic DALMANE *Flurazepam DANOCRINE Danazol DANTRIUM Dantrolene DARAPRIM Pyrimethamine DARBID Isopropamide DARVON *Propoxyphene DAYPRO Oxaprozin DDAVP Desmopressin DECADRON Dexamethasone DECLOMYCIN Demeclocycline DELALUTIN Hydroxyprogesterone DELATESTRYL...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Dacarbazine to Etretinate
Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Dacarbazine to Etretinate Generic Trade Name Dacarbazine DTIC-DOME Dactinomycin COSMEGEN Danazol DANOCRINE Dantrolene DANTRIUM Daunorubicin CERUBIDINE Deferoxamine DESFERAL Delavirdine RESCRIPTOR Demeclocycline DECLOMYCIN Desipramine NORPRAMIN, PERTOFRANE Desmopressin DDAVP, STIMATE Dexamethasone...
Microsoft Word - Medication_Listing.doc page 21
author: Wendy Daws
Microsoft Word - ASL - 01 Autosub List.doc
Drops Biaxin® (RS 30) use in pneumonia 250 500mg bid Zithromax®; unless meets RS 30 criteria 500 mg then 250mg od on day 1 od X 4 days calcium carbonate Lowest Cost Alternative Cascara® Senokot® clarithromycin (Biaxin®) (RS 30) use in pneumonia 250 500 mg bid azithromycin (Zithromax®); unless meets RS 30 criteria...
author: Wendy Daws
Microsoft Word - ASL - 01 Autosub List.doc page 2
author: Wendy Daws
Microsoft Word - Master_Index.doc
Continuing Care Pharmacy & Therapeutics Formulary ML- Index SECTION SUBJECT Page 1 of 58 MASTER INDEX Medication Listing Index YY MM DD Original 00 10 30 Revised 01 12 19 Revised 03 10 23 DRUG NAME PAGE CLASS 5- FU Refer to Province Wide Services (PWS- 02) 35 84: 36 Abenol® 14 28: 08.92 Accupril® Restricted Status (RS- 08), Autosubstitution to benazepril or captopril (ASL-...
author: Wendy Daws
Microsoft Word - Master_Index.doc page 14
author: Wendy Daws
duplicates:http://www.crha-health.ab.ca/clin/cme/ccmed/ccform/mindexd.pdf
Microsoft Word - Master_Index.doc
05% (Tridesilon®) Autosubstitution to betamethasone valerate 0.05% (ASL- 01) 33 84: 06 Desquam- X® 35 84: 28 Desyrel® 17 28: 16.04 dexamethasone (Decadron®) 29 68: 04 Continuing Care Pharmacy & Therapeutics Formulary ML- Index SECTION SUBJECT Page 14 of 58 MASTER INDEX Medication Listing Index YY MM DD Original 00 10 30 Revised 01 12 19 Revised 03 10 23 DRUG NAME...
author: Wendy Daws
Formulations Frequently Asked Questions
Please feel free to talk to us, we are prepared to answer your questions - H ow to choose the right ion exchange resin - R : Despite the fact that there are a limited number of ion exchange resins to choose from, there are some guidelines as to which type of product may be best suited to a particular application A single dosage of - 200 mg is likely to require a significant...