Prescription and OTC Drug Product List 8/1999 RTU IN PLASTIC CONTAINER - DLT - MAR 19, 1999 - ADD - AP + BAXTER HLTHCARE 500MG/100ML N18657 001 - DLT - AP + SCS 500MG/100ML N18657 001 LORACARBEF MINOCYCLINE HYDROCHLORIDE CAPSULE; ORAL LORABID CAPSULE; ORAL - ADD - KING PHARMS 200MG N50668 001 - DLT - MINOCYCLINE HCL - ADD - DEC 31, 1991 - DLT - AB WARNER CHILCOTT EQ 50MG BASE N63066 001 - ADD - + 400MG N50668 002 - DLT -...
http://www.fda.gov/cder/orange/appendix_a.txt 2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt PETERSBURG, FL" 14874 10-May-00 OPOCRIN LABORATORIO FARMACOBIOLOGICA SULODEXIDE AS MANUFACTURED IN CORLO (MODENA) ITALY 14882 19-May-00 REILLY INDUSTRIES INC NIACINAMIDE USP AS MFG IN INDIANAPOLIS IN 14884 15-May-00 SANKYO PHARMA GMBH CS-866(5 10 20 & 40MG) TABLETS AS MFG IN PFAFFENHOFEN GERMANY 14888 05-Nov-96 PROCLINICAL "ENCAPSULATION PROCESS AS PERFORMED AT PHONIXVILLE, PA"...
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 CORPORATION
SSCI Inc.: X-ray Powder Diffraction, Raman and Infrared Spectroscopy, Differential Scanning Calorimetry, and Thermogravimetric Phone: 800 375-2179 / 765 463-0112 Fax: 765 497-2649 / 765 463-4722 E-mail: info@ssci-inc.com SSCI Inc., 3065 Kent Avenue, West Lafayette, IN 47906 - 1076 USA Acetaminophen Acetazolamide Acetohexamide Acetylcysteine Acyclovir Adenine L-Alanine Albuterol Albuterol Sulfate Allopurinol Alprazolam Amantadine HCl Amiloride HCl Aminobenzoic Acid Aminoglutethimide Aminosalicylic Acid...
author: SSCI Webmaster
18_Kits(281-293) page 6
author: Matt Bolgar
subject: 18_Kits(281-293)
Prescription and Over-the-Counter Drug Product List: 1/2004 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETYLCYSTEINE >A> INJECTABLE; INTRAVENOUS >A> ACETADOTE >A> + CUMBERLAND PHARMS 6GM /30ML(200MG/ML) N21539 001 JAN 23, 2004 JAN NEWA ALBUTEROL SULFATE TABLET, EXTENDED RELEASE; ORAL ALBUTEROL SULFATE >D> AB PLIVA EQ 4MG BASE N76130 002 SEP 26, 2002 JAN CRLD >A> + EQ 4MG BASE N76130 002 SEP 26, 2002 JAN CRLD >D> AB EQ 8MG BASE...
Prescription and Over-the-Counter Drug Product List: 6/2003 4 >D> + ROBINS AH 325MG;60MG N84446 001 JUN DISC >A> @ 325MG;60MG N84446 001 JUN DISC ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE; ORAL DIAMOX >A> @ DURAMED PHARM BARR 500MG N12945 001 JUN CAHN >A> + 500MG N12945 003 APR 25, 1995 JUN CAHN >D> @ LEDERLE 500MG N12945 001 JUN CAHN >D> + 500MG N12945 003 APR 25, 1995 JUN CAHN TABLET; ORAL >A> AB DURAMED PHARM BARR 125MG N08943 001 JUN CAHN ...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 3/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG;30MG N40441 001...
author: AUTHOR
FDA Drug Approvals List October 2001 Active Ingredient(s): OXAPROZIN OTC/RX Status: RX Original Abbreviated Application # 075839 Approval Date: 1-OCT-01 Trade Name: MINOXIDIL Dosage Form: SOLUTION Applicant: NOVEX PHARMA Active Ingredient(s): MINOXIDIL OTC/RX Status: RX Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval Original Abbreviated Application #: 075834 Tentative Approval Date: 30...
FDA Drug Approvals List June 2002 - Drug Approvals for June 2002 Definitions and Notes Original New Drug Applications Original Application # 021316 Approval Date: 26-JUN-02 Trade Name: ALTOCOR Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: AURA LABORATORIES INC Active Ingredient(s): LOVASTATIN OTC/RX Status: RX INDICATION OF USE: For lowering total cholesterol and LDL-C to target levels as...
Prescription and OTC Drug Product List 10/2001 PEDIATRIC -D- + ASTRAZENECA 80MG/VIAL;0.02MG/VIAL;0.00 1MG/VIAL;5MG/VIAL;0.01MG/V IAL;0.14MG/VIAL;17MG/VIAL; 0.2MG/VIAL;1MG/VIAL;1.4MG/ VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/V IAL N18920 001 SEP 21, 2000 OCT CAHN -A- + NEOSAN PHARMS 80MG/VIAL;0.02MG/VIAL;0.00 1MG/VIAL;5MG/VIAL;0.01MG/V IAL;0.14MG/VIAL;17MG/VIAL; 0.2MG/VIAL;1MG/VIAL;1.4MG/ VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/V IAL...
Prescription and OTC Drug Product List 9/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- ENDO PHARMS 400MG;5MG N40288 001 NOV 27, 1998 SEP CTEC -D- 400MG;7.5MG N40288 002 NOV 27, 1998 SEP CTEC -D- 400MG;10MG N40288 003 NOV 27, 1998 SEP CTEC -A- + 400MG;5MG N40288 001 NOV 27, 1998 SEP CTEC -A- + 400MG;10MG N40288 003 NOV 27, 1998 SEP CTEC -A- + 400MG;7.5MG...
Prescription and OTC Drug Product List 6/2002 PEDIATRIC -A- + AAIPHARMA 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL; 5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17 MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/V IAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL N18920 001 SEP 21, 2000 JUL CAHN -D- + NEOSAN PHARMS 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL; 5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17 MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/V IAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL...
Prescription and OTC Drug Product List 4/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL ACETAMINOPHEN, BUTALBITAL, CAFFEINE, AND CODEINE PHOSPHATE -A- AB VINTAGE PHARMS 325MG;50MG;40MG;30MG N75929 001 APR 22, 2002 APR NEWA ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; ...
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
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...
Prescription and OTC Drug Product List 2/2001 Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 2: January-February 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL AMOXICILLIN CAPSULE; ORAL CAPSULE; ORAL - DLT - TRIAPRIN AMOXICILLIN - DLT - DUNHALL 325MG;50MG N89268 001 - DLT - AB LABS ATRAL 250MG N62528 001 - DLT - JUL 02,...
FDA Drug Approvals List- March 1998 PEDIATRIC Dosage Form: INJECTABLE Applicant: ASTRA USA INC Active Ingredient(s): ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E OTC/RX Status: RX Application #: 050672 Labeling Supplement #: 012 To...
FDA Drug Approvals List- April 1999 Original Application #: 050760 Approval Date: 15-APR-99 Trade Name: AMOXIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: SUSPENSION Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): AMOXICILLIN OTC/RX Status: RX Indication(s):For the use of Amoxil for oral suspension 200mg/5mL and 400mg/5mL in divided doses q12h Original Application #: 020924 Approval...
FDA Drug Approvals List September 2000 PEDIATRIC Dosage Form: INJECTABLE Applicant: ASTRAZENECA LP Active Ingredient(s): ASCORBIC ACID; VITAMIN A; ERGOCALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; DEXPANTHENOL; VITAMIN E; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; PHYTONADIONE; NIACINAMIDE OTC/RX Status: RX Application #: 050679 Labeling Supplement#: 013 To...
DDPA April 1996 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 20-262 TAXOL BRISTOL MYERS SQUIBB PACLITAXEL 01-APR-96 (INJECTABLE) WALLINGFORD, CT 6MG/ML 06492 (LABELING REVISION -- BOXED WARNING; DESCRIPTION; WARNINGS; PRECAUTIONS; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION; HOW SUPPLIED) 18-602 CARDIZEM HOECHST MARION RSSL DILTIAZEM HYDROCHLORIDE 02-APR-96 (TABLET) KANSAS CITY, MO 30MG 64134...
Bio-Serv - Ingredients Ingredients and Vitamin/Mineral Mixtures Diet Ingredients Ingredients are listed in alphabetical order.
FDA Drug Approvals List July 2002 PEDIATRIC Dosage Form: INJECTABLE Applicant: NEOSAN PHARMACEUTICALS Active Ingredient(s): ASCORBIC ACID; VITAMIN A; ERGOCALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; DEXPANTHENOL; VITAMIN E; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; PHYTONADIONE; NIACINAMIDE OTC/RX Status: RX Application #: 018154 Labeling Supplement #:...
Prescription and OTC Drug Product List 8/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -A- AA ABLE 300MG;30MG N40452 001 AUG 01, 2002 AUG NEWA -A- AA 300MG;60MG N40459 001 AUG 01, 2002 AUG NEWA ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE TABLET; ORAL ACETAMINOPHEN AND PENTAZOCINE HCL -A- AB AMIDE PHARM 650MG;EQ 25MG BASE N76202 001...
