PDF_JAN-FEB-07_newsletter.pdf See "Products" on Pages 2 & 3 For those who visit the Samaritan Pharmaceuticals Website, from time to time, get ready for something completely different to flash on your screen.
author: OEM
PDF_JAN-FEB-07_newsletter.pdf page 3
author: OEM
IROA - Scientific Study Reference Search Pellets 2-Acetamidofluorene (2-AAF) 2-Acetylaminofluorene (AAF) 2-OHE1 3,3',5-Triiodo-L-Thyronine (T3) 4-Hydroxyandrostene-3,17-dione (4-OHA) 4-Hydroxyandrostenedione 5a-Androstan-3a + 17ss-diol 5a-Dihydrotestosterone (5a-DHT) 5a-Dihydrotestosterone (5a-DHT) 5a-Reductase Inhibitor (4MA) 5-Bromo-2'-Deoxyurdine (BrDU) 5a-Dihydrotestosterone (5a-DHT) 6-n-Propyl-2-Thiouracil (PTU...
Drug Approvals - N ANDA 74-471 3/19/98 - - 3/15/99 Nallpen (nafcillin sodium) Injection, in Plastic Container, PL 2040,- Baxter Healthcare Corporation NDA 50-655/S13 8/7/03 8/15/03 Naltrexone Hydrochloride Tablets, 25, 50 & 100mg, Rx Mallinckrodt, IncNaltrexone Hydrochloride Tablets, 50 mg Barr Laboratories ANDA 74-918 5/8/98 5/8/98 - 3/19/99 ...
http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN PHENAPHEN-650 W/ CODEINE, ACETAMINOPHEN PHENAZINE, PHENDIMETRAZINE TARTRATE PHENAZINE-35, PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDE PHENERGAN PLAIN, PROMETHAZINE HYDROCHLORIDE PHENERGAN VC W/ CODEINE, CODEINE PHOSPHATE PHENERGAN VC, PHENYLEPHRINE HYDROCHLORIDE PHENERGAN W...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt MEXICO" 15079 06-Oct-00 MAYNE PHARMA (USA) "PACLITAXEL EXTRACT AS MFG IN BOULDER, COLORADO" 15081 05-Oct-00 PROCOS SPA PRODOTTI CHIMICI "THIAPROLINE-M-AMINO BENZOIC ACID HYRDOCHLORIDE CHEMICAL INTERMEDIATE FOR MK826 AS MFG IN CAMERI(NOVARA), ITALY" 15082 06-Oct-00 NORAC CO INC "DRONABINOL AS MANUFACTURED IN AZUSA, CALIFORNIA" 15083 10-Oct-00 MOEHS IBERICA BISOPROLOL FUMARATE AS MFG...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls IN BUDAPEST, HUNGARY PLANTEX LTD CHEM AND PHARM WORKS IMIPRAMINE HYDROCHLORIDE LUNDBECK PHARMACEUTICALS ITALY SPA IMIPRAMINE HYDROCHLORIDE AVENTIS PHARMA SA PROMETHAZINE HCL GRUPPO LEPETIT SPA D-PROPOXYPHENE HYDROCHLORIDE BULK SCHERING AG ETHINYL ESTRADIOL ROCHE COLORADO CORPORATIONHYDROCHLORIDE (LA 6023) BOEHRINGER INGELHEIM CHEMICALS INC...
75-434 Naltrexone Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Naltrexone Hydrochloride Tablets Company:--Eon Labs Manufacturing, Inc
author: Paul Stauffer
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004 - TABLET/CAPSULES; ORAL Denied 3/1/2001- NALTREXONE HYDROCHLORIDE 25MG, 100MG & 150MG - 99P-4775/CP1 LACHMAN CONSULTANT SERVICES - TABLET; ORAL Approved 4/13/2000- CEFAZOLIN SODIUM, STERILE 100 G & 300 G - 99P-4870/CP1 QUINN CONSULTING SERVICES - FOR INJECTION Approved 4/12/2002- CEFUROXIME SODIUM, STERILE 75 G & 225 G - 99P-4871/CP1 QUINN CONSULTING SERVICES - FOR...
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004 SAIF - TABLETS Pending - METOPROLOL TARTRATE 25 mg - 02P-0460/CP1 CARACO PHARMACEUTICAL - TABLETS Approved 2/13/2003- METOPROLOL TARTRATE 25 mg - 02P-0459/CP1 LACHMAN CONSULTANT SERVICES - TABLETS Approved 2/13/2003- MIDAZOLAM 5 MG/ML-10 ML VIALS - 01P-0136/CP1 ABBOTT LABORATORIES - INJECTION Approved 8/5/2002- MIDODRINE HYDROCHLORIDE 15 MG - 01P-0081/CP1 LACHMAN CONSULTANT...
ANDA Approvals: March, 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - March 2002 - ANDA Number Drug Name Applicant Approval Date 1 75-385 BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG, AND 15 MG ZENITH GOLDLINE PHARMACEUTICALS, INC
author: AmesT
FDA Drug Approvals List May 2001 Pylori eradication to reduce the risk of duodenal ulcer recurrence, maintenance of healed duodenal ulcers, short-term treatment of active benign gastric ulcer, short-term treatment of symptomatic gastroesophageal reflux disease (GERD), short-term treatment of erosive esophagitis, maintenance of healing of erosive esophagitis, and pathological hypersecretory conditions including...
FDA Drug Approvals List March 2002 - Drug Approvals for March 2002 Definitions and Notes Original New Drug Applications Original Application #: 020855 Approval Date: 21-MAR-02 Trade Name: MESNA Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: ASTA MEDICA AG Active Ingredient(s): MESNA OTC/RX Status: RX Indication(s): For the use as a prophylactic agent in reducing the incidence of ifosfamide...
Prescription and OTC Drug Product List 11/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 325MG;5MG N40478 001 NOV 08, 2002 NOV NEWA -A- AA 500MG;10MG N40473 001 NOV 06, 2002 NOV NEWA -A- AA 500MG;5MG N40477 001 NOV 06, 2002 NOV NEWA AMCINONIDE LOTION; TOPICAL -A- AMCINONIDE -A- AB ALTANA 0.1% N76329 001 NOV 06, 2002 NOV NEWA CYCLOCORT -D- + FUJISAWA...
Prescription and OTC Drug Product List 3/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ALBUTEROL SULFATE AEROSOL, METERED; INHALATION PROVENTIL-HFA -D- + 3M EQ 0.09MG BASE/INH N20503 001 AUG 15, 1996 MAR CTEC -A- BX + EQ 0.09MG BASE/INH N20503 001 AUG 15, 1996 MAR CTEC VENTOLIN HFA -D- + GLAXOSMITHKLINE EQ 0.09MG BASE/INH N20983 001 APR 19, 2001 MAR CTEC -A- BX + EQ 0.09MG BASE/INH N20983 001 APR 19, 2001 MAR CTEC...
http://www.medvet.com.au/downloads/drg_scr/sitescreen_product_insert.pdf M e t h a d o n e: Methadone is a synthetic analgesic drug that is originally used in the treatment of narcotic addicts. Among the psychological effects induced by using methadone are analgesia, sedation and respiratory depression. Overdose of methadone may cause coma or even death. It is administered ...
http://www.medvet.com.au/downloads/drg_scr/sitescreen_product_insert.pdf page 2 PERFORMANCE CHARACTERISTICS A. Accuracy For each individual drug screen assay, approximately 60 urine samples of specific drugs were obtained form clinical laboratories. The concentration of drug present in the samples was determined by either GC/ MS or commercial kits. Each sample was then ...
Prescription and OTC Drug Product List 3/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 3: March 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST LIST 20TH EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 3 / JAN'2000 - MAR'2000 ACETAMINOPHEN; BUTALBITAL AMINOPHYLLINE CAPSULE; ORAL TABLET; ORAL PHRENILIN...
FDA Drug Approvals List- May 1998 In this setting, INTEGRILIN has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction, or need for urgent intervention Original Application #: 020774 Approval Date: 15-MAY-98 Trade Name: PERIO CHIP Chemical Type: 3 Therapeutic Potential: S Dosage Form: CHIP Applicant: PERIO PRODUCTS LTD Active Ingredient(s): CHLORHEXIDINE GLUCONATE OTC/RX Status:...
FDA Drug Approvals List- May 1999 Efficacy Supplemental New Drug Applications Application #: 020584 Efficacy Supplement#: 003 Type: SE2 to Original New Drug Application Approval Date: 27-MAY-99 Trade Name: LODINE XL Dosage Form: TABLET, EXTENDED RELEASE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): ETODOLAC OTC/RX Status: RX Efficacy Claim: For the management of the signs and symptoms of...
FDA Drug Approvals List March 2000 Original Application #: 021124 Approval Date: 17-MAR-00 Trade Name: LAMISIL Chemical Type: 6 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: NOVARTIS PHARMACEUTICALS CORP DBA SANDOZ PHARMACEUTICALS CORP Active Ingredient(s): TERBINAFINE HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the treatment of interdigital-type pedis (athlete’s foot), tinea cruris (jock...
http://www.fda.gov/cder/foi/appletter/2000/75434ltr.pdf ANDA 75- 434 March 8, 2000 Eon Labs Manufacturing, IncNaltrexone Hydrochloride Tablets USP, 50 mg
http://www.fda.gov/cder/foi/appletter/2000/75434ltr.pdf page 1
75274LTR.PDF ANDA 75- 274 May 26, 1999 Amide Pharmaceutical, IncNaltrexone Hydrochloride Tablets USP, 50 mg
author: Unknown
75274LTR.PDF page 1
author: Unknown
