Prescription and Over-the-Counter Drug Product List: 12/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> + MIKART 750MG;50MG;40MG N40496 001 DEC 23, 2003 DEC NEWA ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE TABLET; ORAL DARVOCET A500 >D> + AAIPHARMA 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA >A> + 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA...
http://www.fda.gov/cder/orange/appendix_a.txt 400, ERYTHROMYCIN ETHYLSUCCINATE E.E.S., ERYTHROMYCIN ETHYLSUCCINATE EC-NAPROSYN, NAPROXEN ECONAZOLE NITRATE, ECONAZOLE NITRATE ECONOCHLOR, CHLORAMPHENICOL ECONOPRED PLUS, PREDNISOLONE ACETATE ECONOPRED, PREDNISOLONE ACETATE EDECRIN, ETHACRYNATE SODIUM EDECRIN, ETHACRYNIC ACID EDETATE DISODIUM, EDETATE DISODIUM EDEX, ALPROSTADIL EDROPHONIUM CHLORIDE PRESERVATIVE FREE,...
NDA Approvals for Calendar Year 2003 NDA APPROVALS FOR CALENDAR YEAR 2003 Updated through December 31, 2003 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21434 Xanax XR Alprazolam Pharmacia and Upjohn FR 3 S 17-Jan-03 21305 Sodium Iodide I-131 Sodium Iodide I-131 DraxImage 3,5 S 24-Jan-03 20414 Pyridostigmine Bromide Pyridostigmine Bromide US Army 3 P 05-Feb-03...
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N21385AP.doc Sertaconazole Nitrate Cream, 2% CARTON LABELS 2g END FLAPS (2) NDC 62794- 170- 47 Physician Sample Ertaczo ™ (sertaconazole nitrate) Cream 2% Sertaconazole Nitrate Cream, 2% CARTON LABELS 15g SIDE PANEL (1) Ertaczo ™ (sertaconazole nitrate) Cream 2% 17Sertaconazole Nitrate Cream, 2%...
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 11808 09-Jan-96 INTERQUIM SA "SERTACONAZOLE NITRATE MANUFACTURED IN BARCELONA, SPAIN." 11809 15-Jan-96 ACS DOBFAR SPA "STERILE TRISODIUM CITRATE DIHYDRATE MANUFACTURED IN TRIBIANO MILANO, ITALY." 11810 16-Jan-96 CHENG FONG CHEMICALS CO LTD "PHENYLPROPANOLAMINE HYDROCHLORIDE MANUFACTURED IN TAIWAN, REPUBLIC OF CHINA." 11811 15-Jan-96 CIPLA LTD "NORFLOXACIN USP MANUFACTURED...
