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,...
ProductCatalog Pr o d u c t s 2 0 0 3/ 2004 PHARMA GROUP LIMITED Bioniche Life Sciences Inc.
author: Kathy Vandermey
duplicates:http://www.bioniche.com/pdf/ProductCatalog.pdf
ProductCatalog page 7
author: Kathy Vandermey
duplicates:http://www.bioniche.com/pdf/ProductCatalog.pdf
ProductCatalog page 3
author: Kathy Vandermey
duplicates:http://www.bioniche.com/pdf/ProductCatalog.pdf
Drug Approvals - D ANDA 75-371 8/27/99 9/2/99 - - Dacarbazine for Injection USP, 200 mg/vial, Rx Gensia Sicor Pharmaceuticals ANDA 75-259 8/27/98 9/2/98 - - Dalmane (flurazepam hydrochloride) Capsules, 15 mg and 30 mg ICN Pharmaceuticals NDA 16-721/S-074 6/14/01 11/22/02 Daraprim (pyrimethamine) Tablets, 25 mg, Rx GlaxoSmithKline NDA 8-578/S16 11/18/03 11/25/03 12/1/03 - Daraprim (pyrimethamine)...
Office of Generic Drugs: News, Announcements and Federal Register Notices from 2002 (Posted 4/7/2003)- The Guidance Draft Guidance for Industry: Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action; Availability - [ TXT ] [ PDF ] The Guidance (Issued and Posted 4/2/2003) Guidance for Industry on Food-Effect Bioavailability and Fed Bioequivalence Studies; Availability.- [ TXT ] [ PDF ]- (Issued and Posted 1/31/2003) The...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 11085 14-Sep-94 ABBOTT LABORATORIES "AMRINONE MANUFACTURED IN NORTH CHICAGO, ILLINOIS." 11087 16-Sep-94 FINE ORGANICS LTD "TVA MANUFACTURED IN CLEVELAND, ENGLAND." 11088 16-Sep-94 WYCKOFF CHEMICAL CO INC "5-HYDROXYMETHYLTHIAZOLE-4-NITROPHENYLCARBONATE HYDROCHLORIDE MANUFACTURED IN SOUTH HAVEN, MI." 11097 23-Sep-94 DSM PHARMA CHEMICALS SOUTH HAVEN INC "DIPHENHYDRAMINE ...
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
http://www.paddocklabs.com/forms/secundum/volume_9_2.pdf Rx ABH Soft Troche (24 troches) Lorazepam 24 mg Diphenhydramine HCl 600 mg Haloperidol 96 mg Aspartame 480 mg Silica gel 240 mg Acacia powder 400 mg Flavor qs Polyethylene glycol 1450 21 g (depending upon mold used) Mix the lorazepam, diphenhydramine HCl and the aloperi- mix using a shear mixing technique
http://www.paddocklabs.com/forms/secundum/volume_9_2.pdf page 5
http://www.paddocklabs.com/forms/secundum/volume_9_2.pdf page 4
Prescription and Over-the-Counter Drug Product List: 8/2003 4 >D> AA + ORTHO MCNEIL PHARM 300MG;60MG N85055 004 AUG DISC >A> @ 300MG;60MG N85055 004 AUG DISC ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA + MALLINCKRODT 500MG/15ML;10MG/15ML N40508 001 AUG 29, 2003 AUG NEWA >D> MIKART 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG CTEC >A> AA 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 6/2003 >D> AT ALLERGAN 1% N61187 001 JUN DISC >A> @ 1% N61187 001 JUN DISC >D> SOLUTION/DROPS; OPHTHALMIC >D> CHLOROPTIC >D> + ALLERGAN 0.5% N50091 001 JUN DISC >A> @ 0.5% N50091 001 JUN DISC >D> CHLOROQUINE HYDROCHLORIDE >D> INJECTABLE; INJECTION >D> ARALEN HCL >D> + SANOFI SYNTHELABO EQ 40MG BASE/ML N06002 002 JUN DISC >A> @ EQ 40MG BASE/ML N06002 002 JUN DISC CHLORPROMAZINE ...
author: AUTHOR
ANDA Approvals May 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - May 2002 - ANDA Number Drug Name Applicant Approval Date 1 65-036 IDARUBICIN HYDROCHLORIDE INJECTION 1 MG/ML; (5 MG/5 ML, 10 MG/10 ML, AND 20 MG/20 ML SINGLE-DOSE VIALS) GENSIA SICOR PHARMACEUTICALS, INCHYDROCHLORIDE FOR INJECTION,...
author: OGD
5988-9745ENUS_Canada.qxd End fittings for just $1 when you purchase an Agilent PrepHT column before December 31, 2003Diphenhydramine Hydrochloride, 2) Oxybutynin Chloride, 3) Terfenadine Injection Volume: 5 µL Sample Concentration: 10 mg/ mL of each compound...
5988-9745ENUS_Canada.qxd page 2
1997 Abbreviated New Drug Applications (Generic Drugs) 074946 11/19/1997 3/30/1998 Adriamycin PFS (Doxorubicin Hydrochloride) Injection ,- Adria Laboratories 63165/S3, S5, S6 7/9/1993 8/8/2002 Albuterol Inhalation Aerolsol, 90 mcg/ActuationHydrochloride [2 MB] Taro Pharmaceuticals 074694 12/13/1996 12/3/1997 Clomipramine Hydrochloride Capsules, 25, 50, & 75 mg
FDA Drug Approvals List May 2002 - Drug Approvals for May 2002 Definitions and Notes Original New Drug Applications Original Abbreviated Antibiotic Application # 065082 Approval Date: 31-MAY-02 Trade Name: CEFPODOXIME PROXETIL Dosage Form: GRANULE, FOR RECONSTITUTION Applicant: RANBAXY LABORATORIES LTD Active Ingredient(s): CEFPODOXIME PROXETIL OTC/RX Status: RX Original Application #: 021292 Approval Date: 31-MAY...
Prescription and OTC Drug Product List 7/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE -A- AB ABLE 325MG;50MG;40MG N40390 001 JUL 23, 2001 JUL NEWA -A- AB 500MG;50MG;40MG N40394 001 JUL 23, 2001 JUL NEWA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA + WATSON LABS 325MG;7.5MG...
Prescription and OTC Drug Product List 5/2002 2 -D- + ROBINS AH 325MG;15MG N84444 001 MAY DISC -A- @ 325MG;15MG N84444 001 MAY DISC SOLUTION; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -D- AA ALPHARMA 120MG/5ML;12MG/5ML N85861 001 MAY CRLD -A- AA + 120MG/5ML;12MG/5ML N85861 001 MAY CRLD TYLENOL W/ CODEINE -D- AA + JOHNSON RW 120MG/5ML;12MG/5ML N85057 001 MAY DISC -A- @ 120MG/5ML;12MG/5ML N85057 001 MAY DISC TABLET; ORAL...
2003 Export Products List Alphabetical ORDER # pms- PRODU TS FORMAT OMPARABLE TO LASSIFI ATION ( System): INDI ATIONS PRODU TS AVAILABLE FOR EXPORT Effe tive: July 2003 LISTINGS IN RED ARE C NTR LLED DRUGS Page: 9 pms- holestyramine - pms- o aine Powder 5760633300 N Covan Syrup 100 mL C0- Actifed Syrup Cough Syrup (Codeine Phosphate, Triprolidine Hydrochloride, 5760633301 N Covan Syrup 500 mL Pseudoephedrine ...
author: Lee S. Ehler
Published in FEDERAL REGISTER in 2000 (Volume 65) Index of Significant OTC Drug Federal Register Publications 1990 – 2003 (Volumes 55 – 68) Updated April 2003 Division of Over- the- Counter Drug Products Office of Drug Evaluation V Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane (HFD- 560) Rockville, MD 20850 Index of Significant OTC Drug Federal Register Publications Page 1 Table of...
author: CDER USER
duplicates:http://www.fda.gov/cder/Offices/OTC/significant_publications_6-13-2003.pdf
Published in FEDERAL REGISTER in 2000 (Volume 65) page 22
author: CDER USER
duplicates:http://www.fda.gov/cder/Offices/OTC/significant_publications_6-13-2003.pdf
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
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 Dexamethasone Acetate Suspension Dexamethasone Sodium Phosphate Dexpanthenol Dextran 40 Dextran 40 in Sodium Chloride Dextran 70 Dextrose < 5% Dextrose- 5%- 70% Dextrose and Sodium Chloride Dezocine 0.03 mg 166.70 + 2.50 mg 2.00 + 0.36 mg 13.89 1.60 units 3.10 + 5.00 mg 1.00 3.57 mcg 1.40 1.86 CSR units 2.69 0.02 ing 0.02 mg 14.30 mcg 1.00 mg 30.00 mg 0.12 mL 7.14 mg 3.00 mg 1.93 mg...
author: FDA / CBER
subject: December 1987 Guideline
