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,...
Prescription and OTC Drug Product List 11/1997 Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 11: Jan '97 - Nov '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE AMANTADINE HYDROCHLORIDE TABLET; ORAL CAPSULE; ORAL PRECOSE - DLT - SYMADINE - DLT - BAYER 25MG N20482 004 - DLT - AB SOLVAY 100MG N71000 001 - DLT - MAY 29, 1997 - DLT - SEP...
A:\SIGNPUBL.RPT PR 10- 26- 82 47FR47520 Bronchodilator PR 1- 25- 83 48FR3382 Bronchodilator correction 4- 29- 83 48FR19470 Metaproterenol meeting notice 5- 6- 83 48FR20502 Republishing of meeting notice 6- 3- 83 48FR24925 Decision on Metaproterenol 8- 30- 83 48FR39242 Antiasthmatic PR and reopening of record 9- 19- 83 48FR41786 Bronchodilator correction 10- 19- 83 48FR48576 Antitussive PR 11- 16- 83...
author: Paul Stauffer
Cold Remedies: Over-the-Counter Drugs: Merck Manual Home Edition Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
Rulemaking History for OTC Cold & Cough Drug Products Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Rulemaking History for OTC Cold and Cough Drug Products Final Monograph (21CFR341):-- Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use [ PDF ] [ HTML ] - Date Federal Register Citation Action 9/9/1976 41FR38312 Advance Notice of...
author: USERNAME
Rulemaking History for OTC Antitussive Drug Products Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Rulemaking History for OTC Antitussive Drug Products Final Monograph (21CFR341):-- Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use [ PDF ] [ HTML ] - Date Federal Register Citation Action 9/9/1976 41FR38312 Advance Notice of Proposed...
author: USERNAME
Significant Publications 1970 s 9- 9- 76 38312 Cough, Cold, Allergy, Bronchodilator and Antiasthmatic (341) (P) 11- 30- 76 52536 Decision on Diphenhydramine as an Antitussive (N) 11- 30- 76 52537 Benylin Expectorant: NOH on Proposal to Deny Approval of Supplemental NDA for OTC Marketing as an Antitussive (N) 12- 10- 76 54032 Decision of Theophylline as a Single Ingredient-- Disagreement with 9- 9- 76...
author: Paul Stauffer
Significant Publications 1970 s page 4
author: Paul Stauffer
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...
