http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA...
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.Methadone, Naloxone Molteni®, Naltrexone®,...
author: OEM
PDF_JAN-FEB-07_newsletter.pdf page 3
author: OEM
What's new at CDER by Date Methadone HCl Injection, aaiPharma, IncHydrochloride Tablets, Mylan Pharmaceuticals Benazepril Hydrochloride Tablets, Ranbaxy Benazepril Hydrochloride Tablets, Andrx Pharmaceuticals Benazepril Hydrochloride Tablets, Genpharm Benazepril Hydrochloride Tablets, Ivax Pharmaceuticals Benazepril ...
author: Paul Stauffer
Drug Approvals - M ANDA 75-972 12/21/01 - - - Methadone HCl Injection, aaiPharma, IncMethadone HCl oral Concentrate, 10 mg/ml Roxane ANDA 40-180 - 5/6/98 - - Methadone HCL Tablets,5mg, 10 mg Tentatively approved Eon Labs ANDA 40-241 5/29/98 6/3/98 - 2/22/99 Methadone Hydrochloride Tablets USP, 40 mg (Dispersible)
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt "DICLOFENAC POTASSIUM, MANUFACTURED IN CORK, IRELAND" 13935 12-Jan-99 TOYAMA CHEMICAL CO LTD "T-3811ME DRUG SUBSTANCE, MANUFACTURED IN OSAKA, JAPAN" 13942 18-Jan-99 BI CHEMICALS INC "METHADONE HYDROCHLORIDE USP, MANUFACTURED IN PETERSBURG, VA" 13944 13-Jan-99 YANGZHOU PHARMACEUTICAL FACTORY "DOXCYCLINE MONOHYDRATE, MANUFACTURED IN JIANGSU PROVINCE, CHINA" 13945 15-Jan-99...
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...
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 - CREAM; TOPICAL Denied 7/3/2002- LOPERAMIDE HYDROCHLORIDE 1 MG - 02P-0424/CP1 BANNER PHARMACAPS - CAPSULE; ORAL Approved 4/14/2003- LOPERAMIDE HYDROCHLORIDE 2 mg - 02P-0380/CP1 BANNER PHARMACAPS - SOFT GELATIN CAPSULES Pending - MERCAPTOPURINE 100 MG - 00P-1645/CP1 McKENNA & CUNEO - TABLET; ORAL Approved 4/17/2001- METFORMIN HYDROCHLORIDE 1000 MG - 03P-0388/CP1...
Prescription and Over-the-Counter Drug Product List: 4/2003 45 -D- XCEL PHARMS 1MG/ML N05929 001 APR CFTG -A- AP + 1MG/ML N05929 001 APR CFTG -A- DIHYDROEROGTAMINE MESYLATE -A- AP PADDOCK 1MG/ML N40475 001 APR 28, 2003 APR NEWA DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL -A- TAZTIA XT -A- AB4 ANDRX PHARMS 120MG N75401 001 APR 10, 2003 APR NEWA -A- AB4 180MG N75401 002 APR 10, 2003 APR NEWA -A- AB4 240MG N75401 003 APR 10,...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 2/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL -A- CODRIX -A- + ANDRX PHARMS 500MG;15MG N40447 001 FEB 26, 2003 FEB NEWA AZATHIOPRINE TABLET; ORAL AZASAN -A- AAIPHARMA LLC 25MG N75252 002 FEB 03, 2003 FEB NEWA -A- AB 50MG N75252 001 JUN 07, 1999 FEB NEWA -A- 75MG N75252 003 FEB 03, 2003 FEB NEWA -A- 100MG N75252 004 FEB 03, 2003...
author: AUTHOR
Prescription and OTC Drug Product List 11/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET; ORAL PERCOCET -A- + ENDO PHARMS 325MG;7.5MG N40434 001 NOV 23, 2001 NOV NEWA -A- + 325MG;10MG N40434 002 NOV 23, 2001 NOV NEWA ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE -A- AB ANABOLIC 325MG;50MG;40MG...
Prescription and OTC Drug Product List 6/2002 ACTHAR GEL -D- BC + QUESTCOR PHARMS 40 UNITS/ML N08372 006 JUL DISC -A- @ 40 UNITS/ML N08372 006 JUL DISC DIATRIZOATE SODIUM SOLUTION; ORAL, RECTAL HYPAQUE -D- AMERSHAM HLTH 40% N11386 003 JUL DISC -A- @ 40% N11386 003 JUL DISC DICLOFENAC SODIUM GEL; TOPICAL SOLARAZE -A- + BIOGLAN PHARMA 3% N21005 001 OCT 16, 2000 JUL CAHN -D- + BIOGLAN PHARMA PLC 3% N21005 001 OCT 16, 2000 JUL CAHN...
Export Products List by System July 2003 page 42
author: Lee S. Ehler
http://www.fda.gov/cder/foi/label/2001/20315s9lbl.pdf ORLAAM ® Levomethadyl cetate Hydrochloride Oral Solution 4065000// 03 RO ANE LABORATORIES, INCHydrochloride Oral Solution Due to its potential for serious and possibly life- threatening, proarrhythmic effects, L M should be reserved for use in the treatment of opiate- addicted patients who fail to show an acceptable response to...
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 Bulk, Group C Meningococcal Polysaccharide Vaccine Group A Meningococcal Polysaccharide Vaccine Group C Meningococcal Polysaccharide Vaccine Group A and C Menotropin Meperidine HCl Injection Mephentermine Sulfate Mepivacaine HCl Mepivacaine HCl and Levonordefrin Meprobamate Injection Meprylcaine HCI and Epinephrine Mercaptomerin Sodium Mersalyl with theophylline Merethoxylline...
author: FDA / CBER
subject: December 1987 Guideline
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 ...
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- April 1998 Application #: 020555 Efficacy Supplement#: 003 Type: SE1 to Original New Drug Application Approval Date: 01-APR-98 Trade Name: AXID AR Dosage Form: TABLET Applicant: WHITEHALL ROBINS HEALTHCARE Active Ingredient(s): NIZATIDINE OTC/RX Status: OTC Efficacy Claim: Provides for treatment of episodic heartburn, acid indigestion and sour stomach Application #: 020393 Efficacy Supplement#:...
FDA Drug Approvals List- March 1998 Drug Approvals for March 1998 Definitions and Notes March 1998 Original New Drug Applications Original Application #: 020827 Approval Date: 30-MAR-98 Trade Name: MONISTAT 3 Chemical Type: 3 Therapeutic Potential: S Dosage Form: CREAM Applicant: ADVANCED CARE PRODUCTS Active Ingredient(s): MICONAZOLE NITRATE OTC/RX Status: OTC Indication(s): For the over-the-counter treatment of...
http://www.fda.gov/cder/ogd/rld/06134s18.PDF page 3
http://www.fda.gov/cder/ogd/rld/06134s18.PDF page 2
Methadone HCl Tablets ANDA 40- 241 Eon Labs Manufacturing, IncMethadone Hydrochloride Tablets USP, 5 mg and 10 mg
subject: ANDA Approval Letter
Methadone HCl Tablets page 1
subject: ANDA Approval Letter
I: 80LTR.PDF page 1
author: Unknown
