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,...
1997 New Drug Application (NDA)
74905 8/26/1997 9/28/01 Follistim Organon 020582 09/29/1997 8/11/2003 Fortovase/Saquinavir Approval Letter [181 KB] Medical Review(s) Part 1 [2.3 MB], & Part 2 [3.5 MB] Chemistry Review(s), Environmental Assessment and/or FONSI, Pharmacology Review(s) [2.5 MB] Statistical Review(s), Clinical Pharmacology & Biopharmaceutics Review(s), Administrative Document(s) [1.9 MB] Hoffman...
FDA Drug Approvals List March 2002
- Drug Approvals for March 2002 Definitions and Notes Original New Drug Applications Original Application #: 020855 Approval Date: 21-MAR-02 Trade Name: MESNA Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: ASTA MEDICA AG Active Ingredient(s): MESNA OTC/RX Status: RX Indication(s): For the use as a prophylactic agent in reducing the incidence of ifosfamide...
Drug Approvals January 1997
Drug Approvals for January 1997 Definitions and Notes January 1997 Original New Drug Applications Original Application #: 050733 Approval Date: 30-JAN-97 Trade Name: ZITHROMAX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PFIZER INC Active Ingredient(s): AZITHROMYCIN OTC/RX Status: RX Indication(s): Treatment of patients with community-acquired...
Wilson's Disease
Adult Health Topics | All Health Topics Find a UMHS Doctor Search Adult Topics Search All Topics This information is approved and/or reviewed by U-M Health System providers but it is not a tool for self-diagnosis or a substitute for medical treatment. Wilson's disease is a recessive genetic disorder that interferes with the body's ability to excrete copper? What are the...
Reference Listed Drug Labeling Approved in March 2002
Approval Date Product Name Active Ingredient(s) Dosage Form NDA No Supp No Mar 1 BICILLIN C-R letter - penicillin G benzathine/ procaine injection 50-138 S-219 - BICILLIN L-A letter - penicillin G benzathine/ procaine injection 50-141 S-215 - COLY-MYCIN S letter - colistin & neomycin sulfates/thonzonium Br /hydrocortisone acetate otic suspension 50-356 S-045 - CUROSURF letter label...
author: USERNAME
C:\Data\My Documents\20458\S002AP.DOC
Tu: Please refer to your supplemental new drug application dated May 3, 2001, received May 4, 2001, submitted under section 505( b) of the Federal Food, Drug, and Cosmetic Act for Galzin (zinc acetate) Capsules This supplemental new drug application provides for revisions to the CLINICAL TRIALS section of the package insert to include the results from a study on the...
author: Alice Kacuba
C:\Data\My Documents\20458\S002AP.DOC page 3
author: Alice Kacuba
C:\Data\My Documents\20458\S002AP.DOC page 1
author: Alice Kacuba
Bibliography- Coulometric Electrochemical Detection in HPLC
-- HPLC Application Bibliography The Use of Coulometric Electrochemical Detection in HPLC | Central Metabolism | Clinical/Clinical Research | Drugs & Pharmaceuticals | Environmental/Exposure | -| Foods and ...
Bibliography- Coulometric Electrochemical Detection | ESA, Inc.
-- HPLC Application Bibliography The Use of Coulometric Electrochemical Detection in HPLC | Central Metabolism | Clinical/Clinical Research | Drugs & Pharmaceuticals | Environmental/Exposure | -| Foods and ...
Bibliography
-- HPLC Application Bibliography The Use of Coulometric Electrochemical Detection in HPLC | Central Metabolism | Clinical/Clinical Research | Drugs & Pharmaceuticals | Environmental/Exposure | -| Foods and ...