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, EPOPROSTENOL SODIUM...
Reference Listed Drug Labeling Approved in February 2000 Erythromycin ethylsuccinate tab 50-297/S-018 Abbott 4 ERYPED Erythromycin ethylsuccinate oral susp 50-207/S-054 Abbott 4 NOVANTRONE Mitoxantrone hydrochloride inj 19-297/S-021 Immunex 4 PCE Erythromycin tab 50-611/S-018 Abbott 4 ACCOLATE Zafirlukast tab 20-547/S-011 Zeneca 7 ZESTRIL Lisinopril tab 19-777/S-037 Zeneca Pharms 7 GASTROCROM Cromolyn Na + oral sol 20-479/S-002...
author: USERNAME
FDA Drug Approvals List February 2000 - Drug Approvals for February 2000 Definitions and Notes Original New Drug Applications Original Application #: 021015 Approval Date: 28-FEB-00 Trade Name: ANDROGEL Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: UNIMED PHARMACEUTICALS INC Active Ingredient(s): TESTOSTERONE OTC/RX Status: RX Indication(s): For replacement therapy in males for conditions...
DOCUMENT INFORMATION PAGE DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 20- 479/ S- 005 Celltech Pharmaceuticals 755 Jefferson Road PGastrocrom (...
author: Colette Jackson
DOCUMENT INFORMATION PAGE page 1
author: Colette Jackson
Marketed Products Celltech Products ...
PDPL PRESCRIPTION DRUG PRODUCT LIST- 16TH EDITION RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 8 / JAN'96 - AUG'96 ACETAMINOPHEN; BUTALBITAL ALPRAZOLAM TABLET; ORAL TABLET; ORAL BUTALBITAL AND ACETAMINOPHEN ALPRAZOLAM - DLT - AB HALSEY 325MG;50MG N89568 001 - ADD - AB NOVOPHARM 2MG N74085 004 - DLT - OCT 05, 1988 - ADD - FEB 26, 1996 - ADD - @ 325MG;50MG N89568 001 - ADD - OCT 05,...
DDPA September 1995 50-685 CEDAX SCHERING PLOUGH CEFTIBUTEN DIHYDRATE 07-SEP-95 (CAPSULE) KENILWORTH, NJ EQ 400MG BASE 07033 (CEPHALOSPORIN) 50-686 CEDAX SCHERING PLOUGH CEFTIBUTEN DIHYDRATE 07-SEP-95 (POWDER, KENILWORTH, NJ EQ 90MG BASE/5ML FOR ORAL 07033 EQ 180MG BASE/5ML SUSPENSION) (CEPHALOSPORIN) 20-498 CASODEX ZENECA BICALUTAMIDE 14-SEP-95 (TABLET) WILMINGTON, DE 50MG 19850 (ANTIANDROGEN) [USE IN...
DDPA February 1996 IT IS USEFUL IN THE DELINEATION OF REGIONS OF REVERSIBLE MYOCARDIAL ISCHEMIA IN THE PRESENCE OR ABSENCE OF INFARCTED MYOCARDIUM] 11-522 ADDERALL 10 RICHWOOD PHARM AMPHETAMINE ASPARTATE 13-FEB-96 (TABLET) FLORENCE, KY 2.5MG (SUPPL-010) 41042 AMPHETAMINE SULFATE 2.5MG DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE 2.5MG (AMPHETAMINE) 11-522 ADDERALL 20 RICHWOOD PHARM...
