http://www.fda.gov/cder/orange/appendix_a.txt
ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
Drug Approvals - K
Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Kaletra (lopinavir) oral solution, 80mg lopinavir/20mg ritonavir NDA 21-035/S13 & S19 5/22/02 5/29/0 2 - - Keppra (levetiracetam)- Tablets, 250 mg, 500 mg, and 750 mg NDA 16-812/S-032 11/14/02 7/31/03 - - Ketamine Hydrochloride Injection USP, 50 mg, Rx Bioniche Pharma (Canada) Ltd
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
LOUIS, MO" 13842 12-Nov-98 MEDICHEM SA "LORATADINE, MANUFACTURED IN GERONA, SPAIN" 13843 12-Nov-98 CHATTEM CHEMICALS INC "AMMONIUM LACTATE, MANUFACTURED IN CHATTANOOGA, TN" 13844 19-Nov-98 CHEMAGIS LTD "GRANISETRON HYDROCHLORIDE, MANUFACTURED IN BEER SHEVA, ISRAEL" 13845 16-Nov-98 NYCOMED AUSTRIA GMBH "4-METHOXYPHENOL, MANUFACTURED IN LINZ, AUSTRIA" 13846 29-Oct-98...
http://www.paddocklabs.com/forms/secundum/volume_9_2.pdf
Drug therapy has included neuroleptics (haloperidol, prochlorperazine), antihistamines (cyclizine, hydroxyzine, dimenhydrinate), anticholinergics (hyoscine), prokinetics (metoclopramide, domperidone, cisapride), 5HT3 antagonists (ondansetron, granisetron), corticosteroids (dexamethasone) and benzodiazepines Rx Morphine Sulfate and Clonidine Hydrochloride Epidural...
Prescription and Over-the-Counter Drug Product List: 7/2003
>A> @ FERRING 5,000 UNITS/VIAL N17055 001 JUL CAHN >A> @ 10,000 UNITS/VIAL N17055 002 JUL CAHN >A> @ 20,000 UNITS/VIAL N17055 003 JUL CAHN >D> @ WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUL CAHN >D> @ 10,000 UNITS/VIAL N17055 002 JUL CAHN >D> @ 20,000 UNITS/VIAL N17055 003 JUL CAHN GRANISETRON HYDROCHLORIDE SOLUTION; ORAL KYTRIL >D> @ ROCHE EQ 2MG BASE/10ML N21238 001 JUN...
author: AUTHOR
NDA Approvals for Calendar Year 2001
Braun 5 S 21-Feb-01 21-235 Prozac Weekly Fluoxetine Hydrochloride Eli Lilly 3 S 26-Feb-01 21-169 Reminyl Galantamine Hydrobromide Janssen Research 1 S 28-Feb-01 21-082 Tavist Allergy/Sinus/Headache Acetaminophen/Clemastine Fumarate/Pseudoephedrine Hydrochloride Novartis 4 S 01-Mar-01 21-257 Travatan Travoprost Alcon 1 P 16-Mar-01 21-262 Alphagan P Brimonidine Tartrate...
author: Brenda Harmon
FDA Drug Approvals List June 2001
- Drug Approvals for June 2001 Definitions and Notes Original New Drug Applications Original Application #: 021288 Approval Date: 29-JUN-01 Trade Name: TRELSTAR Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: DEBIO RECHERCHE PHARMACEUTIQUE SA Active Ingredient(s): TRIPTORELIN PAMOATE OTC/RX Status: RX Indication(s): For the palliative treatment of...
Prescription and OTC Drug Product List 6/2002
-D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML...
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s
GRANISETRON HYDROCHLORIDE ROCHE 20-239 SE1 008 22-Oct-01 16-Aug-02- - 9.8 Provides for the use of KYTRIL (granisetron HCL) Injection for the prevention and treatment of postoperative nausea and vomiting ----------- This list is updated quarterly.- Updated through 12/31/02 -------------------- Top of Page ---------- EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR...
author: Darlene Norris
Handbook 8/02 corr for Web page 4
author: Diane Ward
Prescription and OTC Drug Product List 6/1998
Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 6: June 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL OXYCODONE AND ACETAMINOPHEN CAPOZIDE 25/15 - ADD - AA DURAMED 325MG;5MG N40272 001 - ADD - AB...
Drug Approvals for May 1997
orbiculare) Application #:020297Efficacy Supplement#:001 Type: SE1 to Original New Drug Application Approval Date: 29-MAY-97 Trade Name: COREG Dosage Form: TABLET Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): CARVEDILOL OTC/RX Status: RX Efficacy Claim: For the new indication of congestive heart failure and a new dosage strength of 3.125 mg Application #...
FDA Drug Approvals List
Active Ingredient(s): NEDOCROMIL SODIUM OTC/RX Status: RX Efficacy Claim: Extending the approved use to the pediatric population of 6-11 years of age Approvable Original New Drug Applications Original Application #: 019781 Approvable Date: 31-MAR-97 Trade Name: PROMETRIUM Dosage Form: CAPSULE Applicant: SCHERING PLOUGH CORP Active Ingredient(s): PROGESTERONE OTC/RX Status: RX...
http://www.fda.gov/cder/rdmt/escy99ap.htm
- - - - - - - - - - TERBINAFINE HYDROCHLORIDE NOVARTIS 20-980 03/30/98 03/09/99 N 0 N 11.3 Rx to OTC switch for the treatment of tinea pedis (athlete's foot), tinea cruris (jock itch) and tinea corporis (ringworm) - - - - - - - - - - GRANISETRON HYDROCHLORIDE SKB PHARMS 20-305 07/27/98 07/27/99 SE1 4 N 12.0 Prevention of nausea and vomiting associated with...
author: Darlene
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...
DDPA November 1995
74-493 CAPTOPRIL PAR CAPTOPRIL 14-NOV-95 (TABLET) SPRING VALLEY, NY 12.5MG 10977 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 19-543 ELOCON SCHERING MOMETASONE FUROATE 03-OCT-95 (OINTMENT) KENILWORTH, NJ 0.1% 07033 (LABELING REVISION -- INDICATIONS AND USAGE; PRECAUTIONS; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION) 19-625...
Drug and Device Approvals March 1995
Drug and Device Approvals-March 1995 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-092 DILACOR XR RHONE POULENC RORER DILTIAZEM HYDROCHLORIDE 02-MAR-95 (CAPSULE, COLLEGEVILLE, PA 120MG (SUPPL-005)EXTENDED RELEASE) 19426 180MG 240MG (NEW INDICATION -- MANAGEMENT OF CHRONIC STABLE ANGINA) 20-281 ULTRAM JOHNSON RW TRAMADOL HYDROCHLORIDE 03-MAR-95 (TABLET)...
Drug Approvals for October 1997
Drug Approvals for October 1997 Definitions and Notes October 1997 Original New Drug Applications Original Application #: 020755 Approval Date: 31-OCT-97 Trade Name: CAVERJECT Chemical Type: 5 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PHARMACIA AND UPJOHN CO Active Ingredient(s): ALPROSTADIL OTC/RX Status: RX Indication(s): Provides for an aqueous formulation for...
THE MERCK MANUAL, Sec. 11, Ch. 144, Principles Of Cancer Therapy
This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 11. Generally, drug therapy is more successful for prophylaxis than for treatment of nausea and vomiting. Virtually no toxicity occurs with granisetron and ondansetron, although headache and, rarely, orthostatic hypotension have occurred with ondansetron. Metoclopramide stimulates the...
THE MERCK MANUAL, Sec. 21, Ch. 294, Care Of The Dying Patient
This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 21. Addressing these factors together with a supportive environment can help cont rol pain. When morphine is given orally, a controlled-release form is preferred because it provides steady levels of morphine with twice-daily dosing (instead of dosing every 3 to 4 h for immediate-release morphine...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, GANTANOL to LYSODREN
Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS GANTANOL to LYSODREN Trade Name Generic GANTANOL Sulfamethoxazole GANTRISIN Sulfisoxazole GARAMYCIN Gentamicin GEOCILLIN Carbenicillin GLUCOPHAGE Metformin GLUCOTROL Glipizide GRIFULVIN V Griseofulvin GRISACTIN Griseofulvin HALCION Triazolam HALDOL Haloperidol HALDRONE Paramethasone HALOTESTIN...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Factor IX concentrates to Itraconazole
Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Factor IX concentrates to Itraconazole Generic Trade Name Factor IX concentrates KONYNE 80, PROPLEX T Famciclovir FAMVIR Famotidine PEPCID Felodipine PLENDIL Fenfluramine PONDIMIN Fenoprofen NALFON Fentanyl SUBLIMAZE Fexofenadine ALLEGRA Filgrastim NEUPOGEN Finasteride PROSCAR, PROPECIA Flavoxate...
THE MERCK MANUAL, Sec. 20, Ch. 278, Radiation Reactions And Injuries
This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 20. Radiation is often characterized in the lay press as low level (0.2 to 0.3 Gy) or high level (> 0.3 Gy). The somatic and genetic effects of doses < 100 mGy are usually estimated by linear extrapolation from studies of higher doses, because few objective data on the effects of very...
THE MERCK MANUAL OF GERIATRICS, Index G
- Index Index-A -| Index-B -| Index-C -| Index-D -| Index-E -| Index-F -| Index-G -| Index-H -| Index-I -| Index-J &n; bsp;| Index-K -| Index-L -| Index-M -| Index-N -| Index-O -| Index-P -| Index-Q -| Index-R -| Index-S -| Index-T -| Index-U -| Index-V -| Index-W -| Index-X,Y,Z Index G Gabapentin 393 , 394t Gag reflex, in dysphagia 1033 Gait (see also Walking ) age-related changes...
Serotonin antagonists (5-HT3 receptor antagonists) - [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 Serotonin antagonists (5-HT3 receptor antagonists) - [Medication] - Quest Diagnostics Patient Health Library Serotonin antagonists (5-HT3 receptor antagonists) - [Medication] - Quest Diagnostics Patient Health Library Brain and nerves, Aloxi, anti-emetics, antiemetics,...