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Application Type Application No. Drug Name Active Ingredients Action Date Company Label
ANDA 040162 PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE 1998-01-20 IVAX SUB TEVA PHARMS View
NDA 020697 TASMAR TOLCAPONE 1998-01-29 VALEANT PHARMS LLC View
ANDA 074929 ETODOLAC ETODOLAC 1998-01-30 ECI PHARMS LLC View
NDA 020805 CIPRO HC CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE 1998-02-10 NOVARTIS PHARMS CORP View
NDA 020763 AMERGE NARATRIPTAN HYDROCHLORIDE 1998-02-10 GLAXOSMITHKLINE LLC View
NDA 020829 SINGULAIR MONTELUKAST SODIUM 1998-02-20 MSD MERCK CO View
ANDA 074936 NAPROXEN NAPROXEN 1998-02-24 ACTAVIS ELIZABETH View
NDA 020803 ALREX LOTEPREDNOL ETABONATE 1998-03-09 BAUSCH AND LOMB View
NDA 020841 LOTEMAX LOTEPREDNOL ETABONATE 1998-03-09 PHARMOS View
NDA 020583 LOTEMAX LOTEPREDNOL ETABONATE 1998-03-09 BAUSCH AND LOMB View
ANDA 075124 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 1998-03-18 MYLAN View
ANDA 074928 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 1998-03-19 EPIC PHARMA View
NDA 020375 CLIMARA ESTRADIOL 1998-03-23 BAYER HLTHCARE View
NDA 020771 DETROL TOLTERODINE TARTRATE 1998-03-25 PHARMACIA AND UPJOHN View
NDA 020895 VIAGRA SILDENAFIL CITRATE 1998-03-27 PFIZER INC View
NDA 020827 MONISTAT 3 MICONAZOLE NITRATE 1998-03-30 MEDTECH PRODUCTS View
NDA 020369 CILOXAN CIPROFLOXACIN HYDROCHLORIDE 1998-03-30 NOVARTIS PHARMS CORP View
NDA 020555 AXID AR NIZATIDINE 1998-04-01 PFIZER View
NDA 020816 AZOPT BRINZOLAMIDE 1998-04-01 NOVARTIS PHARMS CORP View
NDA 020555 AXID AR NIZATIDINE 1998-04-01 PFIZER View