• English
  • 简体中文
Login Register
Current Location: Home > Orange Book Search (FDA) Feedback Help
-
-
-
-
-
Export data
Application No Product No Proprietary Name Active Ingredient Dosage Form;Route Strength Company Approval Date RLD Marketing Status TE Code
(NDA) 021131 001 ZYVOX LINEZOLID SOLUTION;INTRAVENOUS 200MG/100ML (2MG/ML) PFIZER 2000-04-18 Yes RX AP
(NDA) 021130 002 ZYVOX LINEZOLID TABLET;ORAL 600MG PFIZER 2000-04-18 Yes RX AB
(NDA) 021131 002 ZYVOX LINEZOLID SOLUTION;INTRAVENOUS 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** PFIZER 2000-04-18 Yes DISCN
(NDA) 021131 003 ZYVOX LINEZOLID SOLUTION;INTRAVENOUS 600MG/300ML (2MG/ML) PFIZER 2000-04-18 Yes RX AP
(NDA) 021132 001 ZYVOX LINEZOLID FOR SUSPENSION;ORAL 100MG/5ML PFIZER 2000-04-18 Yes RX AB
(NDA) 021130 001 ZYVOX LINEZOLID TABLET;ORAL 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** PFIZER 2000-04-18 Yes DISCN
(NDA) 202379 002 ZYTIGA ABIRATERONE ACETATE TABLET;ORAL 500MG JANSSEN BIOTECH 2017-04-14 Yes RX AB
(NDA) 202379 001 ZYTIGA ABIRATERONE ACETATE TABLET;ORAL 250MG JANSSEN BIOTECH 2011-04-28 Yes RX AB
(NDA) 021150 002 ZYRTEC-D 12 HOUR CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG;120MG J AND J CONSUMER INC 2007-11-09 Yes OTC
(NDA) 019835 006 ZYRTEC HIVES RELIEF CETIRIZINE HYDROCHLORIDE TABLET;ORAL 10MG J AND J CONSUMER INC 2007-11-16 Yes DISCN
(NDA) 019835 005 ZYRTEC HIVES RELIEF CETIRIZINE HYDROCHLORIDE TABLET;ORAL 5MG J AND J CONSUMER INC 2007-11-16 Yes DISCN
(NDA) 019835 004 ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE TABLET;ORAL 10MG J AND J CONSUMER INC 2007-11-16 Yes OTC
(NDA) 022578 001 ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING;ORAL 10MG J AND J CONSUMER INC 2010-09-03 Yes OTC
(NDA) 019835 003 ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE TABLET;ORAL 5MG J AND J CONSUMER INC 2007-11-16 Yes DISCN
(NDA) 020346 001 ZYRTEC CETIRIZINE HYDROCHLORIDE SOLUTION;ORAL 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** J AND J CONSUMER INC 1996-09-27 No DISCN
(NDA) 021086 001 ZYPREXA ZYDIS OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 5MG CHEPLAPHARM 2000-04-06 Yes RX AB
(NDA) 021086 002 ZYPREXA ZYDIS OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 10MG CHEPLAPHARM 2000-04-06 Yes RX AB
(NDA) 021086 004 ZYPREXA ZYDIS OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 20MG CHEPLAPHARM 2000-04-06 Yes RX AB
(NDA) 021086 003 ZYPREXA ZYDIS OLANZAPINE TABLET, ORALLY DISINTEGRATING;ORAL 15MG CHEPLAPHARM 2000-04-06 Yes RX AB
(NDA) 022173 003 ZYPREXA RELPREVV OLANZAPINE PAMOATE SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR EQ 405MG BASE/VIAL CHEPLAPHARM 2009-12-11 Yes RX