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,...
../99/11-642S012_Cardioquin
Food and Drug Administration Center for Drug Evaluation and Research Title Search Cardioquin (Quinidine Polygalacturonate) Tablets Company:--The Purdue Frederick Company Application No.:--11-642/S12 Approval Date:-6/16/1999 Approval Letter(s) - Printed Labeling - Chemistry Review(s) - Administrative Document(s) - - Back to Drug Approval Page Some documents...
author: USERNAME
Prescription and OTC Drug Product List 9/2000
Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 9: September 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE - ADD - ARSENIC TRIOXIDE TABLET; ORAL - ADD - INJECTABLE; INJECTION HYDROCODONE BITARTRATE AND ACETAMINOPHEN - ADD - TRISENOX - ADD - AA MALLINCKRODT 325MG...
FDA Drug Approvals List- June 1999
ROBINS COMPANY Active Ingredient(s): ISOSORBIDE MONONITRATE OTC/RX Status: RX Application #: 018074 Labeling Supplement#: 029 To Original New Drug Application Approval Date: 16-JUN-99 Trade Name: PHENDIMETRAZINE TARTRATE Dosage Form: CAPSULE, EXTENDED RELEASE Applicant: EON LABORATORIES Active Ingredient(s): PHENDIMETRAZINE TARTRATE OTC/RX Status: RX Application #: 012940 Labeling...
FDA Drug Approvals List- July 1998
Drug Approvals for July 1998 Definitions and Notes July 1998 Original New Drug Applications Original Application #: 020822 Approval Date: 17-JUL-98 Trade Name: CELEXA Chemical Type: 1 Therapeutic Potential: S Dosage Form: TABLET Applicant: FOREST LABORATORIES INC Active Ingredient(s): CITALOPRAM HYDROBROMIDE OTC/RX Status: RX Indication(s): TREATMENT OF DEPRESSION Original...
DDPA July 1995
74-477 CAPTOPRIL HALLMARK PHARMA CAPTOPRIL 31-JUL-95 (TABLET) SOMERSET, NJ 12.5MG 08873 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 17-087 ETHRANE OHMEDA ENFLURANE 05-JUL-95 (LIQUID) LIBERTY CORNER, NJ 99.9% 07938 (LABELING REVISION -- PRECAUTIONS) 17-624 FORANE OHMEDA ISOFLURANE 05-JUL-95 (LIQUID) LIBERTY CORNER, NJ 99.9%...
http://www.fda.gov/cder/da/ddpa93.wpd
73 138 TRAZODONE HCL MUTUAL PHARM TRAZODONE HYDROCHLORIDE 03 23 93 (TABLET) PHILADELPHIA, PA 150MG 19124 (ANTIDEPRESSANT) 73-653 METOPROLOL TARTRATE MUTUAL PHARM METOPROLOL TARTRATE 03-30-93 (TABLET) PHILADELPHIA, PA 50MG 19124 (BETA ADRENERGIC BLOCKER) 73-654 METOPROLOL TARTRATE MUTUAL PHARM METOPROLOL TARTRATE 03-30-93 (TABLET) PHILADELPHIA, PA 100MG 19124 (BETA ADRENERGIC BLOCKER)...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, CALAN to CYTOXAN
Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS CALAN to CYTOXAN Trade Name Generic CALAN Verapamil CALCIMAR Calcitoninsalmon CALDEROL Calcifediol CAPASTAT Capreomycin CAPOTEN Captopril CARAFATE Sucralfate CARDENE Nicardipine CARDIOQUIN Quinidine CARDIZEM Diltiazem CARDURA Doxazosin CARTROL Carteolol CATAFLAM Diclofenac CATAPRES...
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...
Quinidine, Serum
Quinidine, Serum ---- Number 007831 CPT 80194 Synonyms Cardioquin ®; Duraquin®; Quinaglute®; Quinidex®; Quinora® Specimen Serum or plasma Volume 1 mL Minimum Volume 0.3 mL Container Red-stopper tube or green-stopper (heparinized plasma) tube. Depending on the specimen volume and storage time, the decrease in drug level due to absorption may be...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, CALAN to CYTOXAN
Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS CALAN to CYTOXAN Trade Name Generic CALAN Verapamil CALCIMAR Calcitoninsalmon CALDEROL Calcifediol CAPASTAT Capreomycin CAPOTEN Captopril CARAFATE Sucralfate CARDENE Nicardipine CARDIOQUIN Quinidine CARDIZEM Diltiazem CARDURA Doxazosin CARTROL Carteolol CATAFLAM Diclofenac CATAPRES...
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...
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_JUL_1998.HTML
Firm Date QUINAGLUTE DURA-TABS Quinidine gluconate ER tablets 16-647 S-035 Berlex 1-July-1998 CARDIOQUIN Quinidine polygalacturonate tablets 11-642 S-011 Purdue Frederick 1-July-1998 LIPITOR Atorvastatin calcium tablet 20-702 S-003 Warner Lambert Export Ltd 10-July-1998 ORTHO-NOVUM 1/50 28 Mestranol/norethindrone tablets 16-709 S-123 RW Johnson 10-July-1998 ORTHO...
http://www.fda.gov/cder/foi/label/2001/20779s32lbl.pdf
AGOURON PHARMACEUTICALS, INC Patients had a mean age of 35 (range 22- 59) were 89% male and 88% Caucasian Pregnancy, Fertility and Reproduction Pregnancy Category B Comparisons of systemic exposure are based on the steady- state area under the plasma concentration time curve (AUC) observed in humans receiving the recommended therapeutic dose VIRACEPT should be taken together...
http://www.fda.gov/cder/foi/label/2001/20779s32lbl.pdf page 21
V:\DAVDP\CSO\BELOUIN\IndigoNda s\NDA\20659-20945\LETTERS\SLR025&005APPROVALLETTER.doc page 30
author: Sean Belouin
4:00 page 10
author: Christine Wildman
09001464801f168b.pdf page 29
author: gracej
duplicates:http://www.fda.gov/cder/foi/label/2002/20659S27lbl.pdf
20-779 S-038 AP VIRACEPT.pdf
AGOURON PHARMACEUTICALS, INC The percent of patients with plasma HIV RNA <50 copies/ mL at 52 weeks was 54% for the VIRACEPT + ZDV + 3TC treatment group and 13% for the ZDV + 3TC treatment group There were also no effects on fetal development or maternal toxicity when nelfinavir was administered to pregnant rats at systemic exposures comparable to human exposure VIRACEPT has...
author: gracej
20-779 S-038 AP VIRACEPT.pdf page 23
author: gracej