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 RTU IN PLASTIC CONTAINER, METRONIDAZOLE FLAGYL I.V., METRONIDAZOLE HYDROCHLORIDE FLAGYL, METRONIDAZOLE FLAREX, FLUOROMETHOLONE ACETATE FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE FLAVOXATE HCL, FLAVOXATE HYDROCHLORIDE FLAXEDIL, GALLAMINE TRIETHIODIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE FLEXICORT, HYDROCORTISONE FLOLAN...
FDA Drug Approvals List February 2001 Approvable Original New Drug Applications - Original Abbreviated New Drug Applications Original Abbreviated Application # 075402 Approval Date: 28-FEB-01 Trade Name: METAPROTERENOL SULFATE Dosage Form: SOLUTION Applicant: NOVEX PHARMA Active Ingredient(s): METAPROTERENOL SULFATE OTC/RX Status: RX Original Abbreviated Application # 075403 Approval Date: 28-FEB-01 Trade Name:...
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s GLYBURIDE AND METFORMIN HYDROCHLORIDE BRISTOL MYERS SQUIBB 21-178 SE1 004 30-Nov-01 30-Sep-02 - 10.0 Provides for the use of Glucovance (Glyburide and Metformin HCl) tablets with a thiazolidinedione when glycemic control is not obtained with Glucovance alone
author: Darlene Norris
C:\Data\My Documents\NDA\N21178S4AP.doc Table 2: Placebo- and Active- Controlled Trial of GLUCOVANCE as Initial Therapy: Summary of Trial Data at 20 Weeks Placebo Glyburide 2.5 mg tablets Metformin 500 mg tablets GLUCOVANCE 1.25 mg/ 250 mg tablets GLUCOVANCE 2.5 mg/ 500 mg tablets Mean Final Dose 0 mg 5.3 mg 1317 mg 2.78 mg/ 557 mg 4.1 mg/ 824 mg Hemoglobin A 1c N = 147 N = 142 N = 141 N = 149...
author: Jena Weber
C:\Data\My Documents\NDA\N21178S4AP.doc page 23
author: Jena Weber
C:\Data\My Documents\NDA\N21178S4AP.doc page 19
author: Jena Weber
C:\Data\My Documents\NDA\N21178S4AP.doc page 17
author: Jena Weber
C:\Data\My Documents\NDA\N21178S4AP.doc page 2
author: Jena Weber
Bristol-Myers Squibb Company GLUCOVANCE (Glyburide and Metformin HCl Tablets) 7/ 31/ 00 Page 1 of 23 Bristol- Myers Squibb Company Rx only GLUCOVANCE (Glyburide and Metformin HCl Tablets) 1.25 mg/ 250 mg 2.5 mg/ 500 mg 5 mg/ 500 mg DESCRIPTION GLUCOVANCE (Glyburide and Metformin HCl Tablets) contains two oral antihyperglycemic drugs used in the management of...
author: Bristol-Myers Squibb Company
Bristol-Myers Squibb Company page 17
author: Bristol-Myers Squibb Company
Bristol-Myers Squibb Company page 13
author: Bristol-Myers Squibb Company
Bristol-Myers Squibb Company page 12
author: Bristol-Myers Squibb Company
Bristol-Myers Squibb Company page 10
author: Bristol-Myers Squibb Company
Bristol-Myers Squibb Company page 8
author: Bristol-Myers Squibb Company
Bristol-Myers Squibb Company page 1
author: Bristol-Myers Squibb Company
Slide 1 n Efficacy n n * peak postprandial glucose n * plasma glucose 3.3-3.9 mmol/L n * HbA1C 1.0-2.0% n n Other Effects n n Hypoglycemia (may be less than with sulfonylureas if patient has a variable eating schedule) Weight gain No significant effect on plasma lipid levels Safe at higher levels of serum Cr than sulfonylureas n n Medications in this Class: repaglinide , nateglinide Alpha...
author: Dr Nyi Nyi Pe and Dr. Khin Swe Myint
Biguanides for type 2 diabetes - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Biguanides for type 2 diabetes - [Medication] - Quest Diagnostics Patient Health Library Biguanides for type 2 diabetes - [Medication] - Quest Diagnostics Patient Health Library Adult Diabetes, adult onset diabetes, adult onset diabetes mellitus,...
Sulfonylureas for type 2 diabetes - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Sulfonylureas for type 2 diabetes - [Medication] - Quest Diagnostics Patient Health Library Sulfonylureas for type 2 diabetes - [Medication] - Quest Diagnostics Patient Health Library Adult Diabetes, adult onset diabetes, adult onset diabetes mellitus,...
Biguanides for type 2 diabetes - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Biguanides for type 2 diabetes - [Medication] - Quest Diagnostics Patient Health Library Biguanides for type 2 diabetes - [Medication] - Quest Diagnostics Patient Health Library Adult Diabetes, adult onset diabetes, adult onset diabetes mellitus,...
C:\Data\Review\NDA review\Diabetis\Glucovance Ped N21178\Summary for Ped.doc Page 1 of 2 OFFICE OF CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW NDA: 21- 178 Submission Date( s): July 21, 2003 Brand Name: Glucovance Generic Name: Glyburide and metformin HCl tablets Reviewer: Sang M
author: Sang Chung
C:\Data\Review\NDA review\Diabetis\Glucovance Ped N21178\Summary for Ped.doc page 1
author: Sang Chung
C:\Data\My Documents\PedRequest\N21178MOExecutiveSumm.doc GLUCOVANCE was not shown statistically to be superior to either metformin or glyburide with respect to reducing HbA1c from baselineGlucovance, metformin alone, and glyburide aloneGlucovance (Metformin/ Glyburide) was not superior to metformin or glyburide monotherapy with respect to reduction in HbA1c
author: Jena Weber
C:\Data\My Documents\PedRequest\N21178MOExecutiveSumm.doc page 3
author: Jena Weber
C:\Data\My Documents\PedRequest\N21178MOExecutiveSumm.doc page 2
author: Jena Weber
