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,...
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
http://www.fda.gov/cder/reports/cderfact.pdf page 21
author: Carolyn Spencer
http://www.fda.gov/cder/reports/cderfact.pdf pylori detection kit Manufacturer SmithKline Beecham Organon Lilly Pharmacia and Upjohn Boehringer Ingelheim Zeneca Gilead Glaxo Wellcome Hoechst Marion Roussel Parke Davis Enviroderm Advanced Magnetics Allergan Meretek Generic Name albendazole mirtazapine lispro irinotecan HCl nevirapine meropenen cidofovir remifentanil HCl fexofenadine HCl fosphenytion sodium bentoquatam ...
author: Carolyn Spencer
C:\WINDOWS\Desktop\Walt\IVYBLOCK\20532S8.doc page 1
author: Walter J. Ellenberg
PDPL - ADD - AB1 0.6MG/HR N89774 001 - DLT - SEARLE 0.35MG N17060 001 - ADD - AUG 30, 1996 - ADD - NOR-QD NITRO-DUR - ADD - + SEARLE 0.35MG N17060 001 - DLT - BX + KEY PHARMS 0.1MG/HR N20145 001 - DLT - APR 04, 1995 - DLT - BX + 0.2MG/HR N20145 002 NYSTATIN - DLT - APR 04, 1995 - DLT - BX + 0.4MG/HR N20145 004 POWDER; TOPICAL - DLT - APR 04, 1995 MYCOSTATIN - DLT - BX + 0.6MG/HR N20145...
DDPA August 1996 DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER TRADE NAME APPLICANT ACTIVE INGREDIENT(S) APPROVAL DATE (DOSAGE FORM) STRENGTH(S) (CLASSIFICATION) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 19-640 HUMATROPE LILLY SOMATROPIN, BIOSYNTHETIC 01-AUG-96 (INJECTABLE) INDIANAPOLIS, IN 5MG/VIAL (SUPPL-013) 45285 (NEW INDICATION --...
August Drug Approvals Original Application #: 020508 Approval Date: 29-AUG-96 Trade Name: LAC-HYDRIN Chemical Type: 3 Therapeutic Potential: S Dosage Form: CREAM Applicant: BRISTOL MYERS CO Active Ingredient(s): AMMONIUM LACTATE OTC/RX Status: RX Indication(s): ICHTHYOSIS VULGARIS AND XEROSIS Original Application #: 020532 Approval Date: 26-AUG-96 Trade Name: IVY BLOCK Chemical Type: 1...
