http://www.fda.gov/cder/orange/appendix_a.txt IRRIGANT, NEOMYCIN SULFATE NEOSPORIN, BACITRACIN ZINC NEOSPORIN, GRAMICIDIN NEOSPORIN, NEOMYCIN SULFATE (OTC) NEOTHYLLINE, DYPHYLLINE NEOTRIZINE, TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE; SULFAMETHAZINE) NEPHRAMINE 5.4%, AMINO ACIDS NEPHROFLOW, IODOHIPPURATE SODIUM, I-123 NEPTAZANE, METHAZOLAMIDE NESACAINE, CHLOROPROCAINE HYDROCHLORIDE NESACAINE-MPF, CHLOROPROCAINE ...
FDA Drug Approvals List May 2001 Pylori eradication to reduce the risk of duodenal ulcer recurrence, maintenance of healed duodenal ulcers, short-term treatment of active benign gastric ulcer, short-term treatment of symptomatic gastroesophageal reflux disease (GERD), short-term treatment of erosive esophagitis, maintenance of healing of erosive esophagitis, and pathological hypersecretory conditions including...
FDA Drug Approvals List March 2001 Original Application #: 021082 Approval Date: 01-MAR-01 Trade Name: TAVIST ALLERGY/SINUS/HEADACHE Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET Applicant: NOVARTIS CONSUMER HEALTH INC Active Ingredient(s): ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE OTC/RX Status: OTC Indication(s): For temporary relief of symptoms associated with hay fever...
Drug Approvals - O Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Ocufen Ophthalmic Solution, (0.03%) Allergan NDA 19-404/S020 8/25/03 8/28/03 8/28/03 - Ocufen Ophthalmic Solution (0.03%) Allergan NDA 19-404/S017 8/17/01 - 4/15/03 - Ocufen Ophthalmic Solution (0.03%) Allergan NDA 19-404/S014 7/30/01 - 4/15/03 - Ofloxacin Injection, 40 mg/mL packaged in 10 mL...
http://www.fda.gov/cder/foi/label/2001/20315s9lbl.pdf ORLAAM ® Levomethadyl cetate Hydrochloride Oral Solution 4065000// 03 RO ANE LABORATORIES, INCORLAAM ® Levomethadyl cetate Hydrochloride Oral Solution Due to its potential for serious and possibly life- threatening, proarrhythmic effects, L M should be reserved for use in the treatment of opiate- addicted patients who fail to show an...
http://www.fda.gov/cder/foi/label/2001/20315s9lbl.pdf page 1
Drug Shortages FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - - Drug Shortages - Introduction FAQs Current Drug Shortages - Resolved Drug Shortages Drugs to be Discontinued - Drug Shortage Manual of Policies and Procedures (MaPP) Medical Necessity Guidance Document How to Report a Drug Shortage - Practical Steps for Practitioners Facing Shortage...
Drug Shortage: Drug to be Discontinued - FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Drug Shortage: Drug to be Discontinued Letter from Roxane August 23, 2003 - PRODUCT DISCONTINUATION NOTICE ORLAAM ® (Levomethadyl hydrochloride acetate) Oral Solution, 10 mg/mL, CII NDC 0054-3649-63 Dear Healthcare Professional: Roxane Laboratories, Inc
Reference Listed Drug Labeling Approved in May 2001 May 1 FLOMAX letter label tamsulosin HCl capsules 20-579 S-007 PREVACID letter label lansoprazole delayed-release capsules 20-406 S-038 May 2 EFFEXOR EFFEXOR XR letter label venlafaxine HCl tablets venlafaxine HCl extended-release capsules 20-151 20-699 S-018 S-016 May 3 BUSPAR letter label buspirone HCl tablets 18-731 S-045 INDERIDE LA 80/50 letter label propranolol HCl/HCTZ...
author: USERNAME
Reference Listed Drug Labeling Approved in March 2001 Mar 1 LUPRON DEPOT 7.5 mg letter label leuprolide acetate for injectable suspension 19-732 S-020 LUPRON DEPOT 3.75 mg letter label leuprolide acetate for injectable suspension 20-011 S-020 LUPRON DEPOT 3 month 11.25 mg letter label leuprolide acetate for injectable suspension 20-708 S-010 LUPRON DEPOT 4 month 30 mg letter label leuprolide acetate for injectable suspension 20-517 S...
author: USERNAME
News Along the Pike, April-May 2001 Food and Drug Administration • Center for Drug Evaluation and Research About CDER Search CDER News Along the Pike April-May 2001 Volume 7, Issue 4 Center for Drug Evaluation and Research PDF version for printouts
author: Oliver
Geodon Consumer Information Therefore do not take Geodon if you have the following heart conditions:- long QT syndrome (a specific heart rhythm problem)- a recent heart attack- severe heart failure- certain irregularities of heart rhythm (discuss the specifics with your doctor)- Do not take Geodon if you are currently taking medications that should not be taken while you are taking Geodon, such as:- dofetilide ...
D:\Data\My Documents\ORLAAM\letters\20315092.doc page 1
author: Sara Shepherd
D:\Data\My Documents\ORLAAM\letters\N20315ap06.dco page 1
author: Sara Shepherd
duplicates:http://www.fda.gov/cder/foi/appletter/2001/20315S6LTR.PDF
CDER News Along the Pike News Along the Pike, May 25, 2001 1 Internal Reference Guide to Replace Quick Index T he CDER Internal Reference Guide, which is designed to help you locate subject matter experts and their phone numbers, is available on CDER's intranet at http:// cdernet/ dcm/ irg
author: Center for Drug Evaluation and Research
subject: Food and Drug Administration
CDER News Along the Pike page 7
author: Center for Drug Evaluation and Research
subject: Food and Drug Administration
