What's new at CDER by Date
- U.S New and Generic Drug Approvals Curosurf (poractant alfa) Intratracheal Suspension, Dey Glyburide & Metformin Hydrochloride Tablets, Ivax Pharmaceuticals HYDREA (hydroxyurea) Capsules, Bristol-Myers Squibb Company Methergine (Methylergonovine Maleate) Tablets & Injection, Novartis M.V.I Benazepril Hydrochloride & Hydrochlorothiazide Tablets, Genpharm Benazepril...
author: Paul Stauffer
CDER: Previous News Items, 2004
FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - Previous News Items, 2004 February 6, 2004 -FDA approves Oxycodone Hydrochloride (non combination product) February 5, 2004 FDA approves first-time generic TriLyte (Polyethylene Glycol 3350, Potassium Chloride, Sodium Bicarbonate and Sodium Chloride for Oral Solution)
Paragraph IV Patent Certifications
- DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
http://www.fda.gov/cder/orange/appendix_a.txt
12, CHLORPHENIRAMINE MALEATE (OTC) CODOXY, ASPIRIN CODRIX, ACETAMINOPHEN COGENTIN, BENZTROPINE MESYLATE COGNEX, TACRINE HYDROCHLORIDE COL-PROBENECID, COLCHICINE COLAZAL, BALSALAZIDE DISODIUM COLBENEMID, COLCHICINE COLD CAPSULE IV, CHLORPHENIRAMINE MALEATE (OTC) COLD CAPSULE V, CHLORPHENIRAMINE MALEATE (OTC) COLESTID, COLESTIPOL HYDROCHLORIDE COLGATE TOTAL, SODIUM FLUORIDE (OTC)...
Cancer.gov - Gastrointestinal complications (PDQ®)
Gastrointestinal complications (PDQ®) Two versions of this document are available Provide a warm or hot drink approximately one-half hour before time of patientas usual defecationPolyethylene glycol and electrolytes (Golytely, Colyte) Five packets are mixed with 1 gallon (3.785 liters) of tap water and contain the following: polyethylene glycol ...
2086PadSec12-2.qxd
RX ANTHRALIN 1% MEDICATION STICK Anthralin 200 mg Polyethylene glycol 3350 6.5 g Polyethylene glycol 300 15 mL Melt the polyethylene glycols together to a temperature about 55° C RX IVERMECTIN 1% CREME RINSE Ivermectin 1 g Polyethylene glycol 300 17 mL Creme Rinse (Commercial) qs 100 mL Mix the ivermectin with the polyethylene ...
author: Mercury
2086PadSec12-2.qxd page 4
author: Mercury
Paddock Laboratories, Inc. - Master Product List
USP (Enteric-Coated Yellow) OTC 0004-01 0004-10 0004-11 5 mg - 100's 5 mg - 1000's 5 mg - U/D 100's - - - [C]--PRODUCTS-- Rx or OTC NDC 0574- Strength / Size MSDS Secundum Artem Issues Biblio- graphy Listing CASTOR OIL USP OTC 3312-02 2 oz Vol 3 No 4 ; Vol 5 No 3 ; Vol 10 No 2 - COLISTIN SULFATE USP POWDER Rx 0417-01 1 BU ** - - COLLODION, FLEXIBLE USP OTC 0560-04 4 oz - - - COLOCORT...
Paddock Laboratories, Inc. - Other OTC's
USP (Enteric-Coated Yellow) CASTOR OIL USP COLLODION, FLEXIBLE USP DERMABASE™ Oil-in-Water Emulsion Base DOCUSATE SODIUM CAPSULES USP FATTIBASE™ (Pre-blended Fatty Acid Suppository Base) FERROUS GLUCONATE TABLETS USP (Green) FERROUS SULFATE TABLETS (Enteric Coated Red) GLUTOSE 15™ GLUTOSE 45™ GLUTOSE TABLETS™ GLYCERIN USP LIQUID HYDROCREAM BASE™ ...
Hampton Research - Optimize - Polymers - Polyethylene Glycol 3350
--Products------ Customer Service------ Technical Support------ Cool Stuff------ About Us------ Search------ - Screens -- Crystallization Optimization -- Optimize Reagents -- Optimize Reagents - Polymers -- Polyethylene Glycol 3350 - Polyethylene Glycol 3350 Specifications: N/A - Mr: 3300-3400 - - - ----------- - - - Ordering...
author: Hampton Research Corp.
POLYBASE.PDF page 2
2-144 Formulations vs 2 page 2
2-144 Formulations vs 2 page 1
2-134 Formulations vs 2 page 2
2-134 Formulations vs 2 page 1
FDA Drug Approvals List June 2001
PERRIGO COMPANY Active Ingredient(s): MONOXIDIL OTC/RX Status: RX Original Abbreviated Application # 075750 Approval Date: 8-JUN-01 Trade Name: DOXAZOSIN MESYLATE Dosage Form: TABLET Applicant: SIDMAK LABORATORIES, INC Active Ingredient(s): DOXAZOSIN MESYLATE OTC/RX Status: RX Original Abbreviated Application # 075502 Approval Date: 05-JUN-01 Trade Name: CLOTRIMAZOLE AND...
Hampton Research - Optimize - Polymers
Ethylene imine Polymer Jeffamine ED-2001 ® Reagent Jeffamine M-600 ® Reagent Pentaerythritol Ethoxylate (3/4 EO/OH) Pentaerythritol Ethoxylate (15/4 EO/OH) Pentaerythritol Propoxylate (5/4 PO/OH) Pentaerythritol Propoxylate (17/8 PO/OH) Polyacrylic Acid 5100 Polyethylene Glycol 200 Polyethylene Glycol 400 Polyethylene Glycol 1000 ...
author: Hampton Research Corp.
PEG/Ion Screen
--Products------ Customer Service------ Technical Support------ Cool Stuff------ About Us------ Search------ - Screens -- Crystallization Screens -- PEG/Ion Screen - PEG/Ion Screen Application - Crystallization screen for soluble proteins - Features Screen a complete profile of anions and cations in the presence of monodisperse Polyethylene Glycol 3350 ...
author: Hampton Research Corp.
Hampton Research - Crystallization Tips
--Products------ Customer Service------ Technical Support------ Cool Stuff------ About Us------ Search------ - Technical Support -- Crystallization Tips - Crystallization Tips Search for crystallization tips using a keyword or simply browse below Using small amphophiles - - When screening detergents as additives be sure to evaluate small amphophiles such as 1,2,3-heptanetriol,...
author: Hampton Research Corp.
FoldIt - Protein Refolding Kit
--Products------ Customer Service------ Technical Support------ Cool Stuff------ About Us------ Search------ - Screens -- FoldIt - Protein Refolding Kit - FoldIt - Protein Refolding Kit Application - Recover folded protein from inclusion bodies If the results of FoldIt indicate that the folding from inclusion bodies is not feasible, then the results of FoldIt justify...
author: Hampton Research Corp.
http://www.fda.gov/cder/foi/label/2001/20698s3lbl.pdf
DESCRIPTION: A white powder for reconstitution MiraLax (polyethylene glycol 3350, NF) is a synthetic polyglycol having an average molecular weight of 3350 This product should be used for 2 weeks or less or as directed by a physician CONTRAINDICATIONS: MiraLax is contraindicated in patients with known or suspected bowel obstruction and patients known to be...
http://www.fda.gov/cder/foi/label/2001/20698s3lbl.pdf page 3
2-229 User Guide
FoldIt evaluates the following protein fold- ing factors: Protein Concentration, Polar Additive (L-arginine), Detergent (lauryl maltoside), pH (6.5 and 8.2), RedOx potential (GSH/GSSG), Chaotrope (Guanidine Hydrochloride), Ionic Strength (NaCl & KCl), Divalent Cations (Mg and Ca or EDTA), PEG, Nonpolar Additive (Sucrose), and Polyethylene glycol (PEG 3350) coli...
author: Kurt Cobain
2-229 User Guide page 1
author: Kurt Cobain
http://www.paddocklabs.com/forms/secundum/volume_5_3.pdf
Formula 2 (with PEG) Acyclovir (200 mg Caps) 6 Polyethylene Glycol 3350 6 15 (Lidocaine 30% Lip Balm) Lidocaine Base 1.5 g Polyethylene Glycol 4000 1 g Polyethylene Glycol 400 2 1700 TABLE 1 MELTING/ CONGEALING POINTS/ RANGES OF WAXES, OILS AND POLYETHYLENE GLYCOLS ITEM MELTING POINT °C CONGEALING POINT °C Waxes...