美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=ORAP"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
ORAP 017473 001 NDA PIMOZIDE TABLET;ORAL 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1984/07/31 1984/07/31 TEVA Discontinued
ORAP 017473 003 NDA PIMOZIDE TABLET;ORAL 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1984/07/31 1997/08/27 TEVA Discontinued
CHLORAPREP ONE-STEP 020832 001 NDA CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL SPONGE;TOPICAL 2%;70% (3ML) Yes Yes 2000/07/14 2000/07/14 BECTON DICKINSON CO Over-the-counter
CHLORAPREP WITH TINT 020832 002 NDA CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL SPONGE;TOPICAL 2%;70% (26ML) Yes Yes 2000/07/14 2005/05/03 BECTON DICKINSON CO Over-the-counter
CHLORAPREP ONE-STEP FREPP 020832 003 NDA CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL SPONGE;TOPICAL 2%;70% (1.5ML) Yes Yes 2000/07/14 2002/04/26 BECTON DICKINSON CO Over-the-counter
CHLORAPREP ONE-STEP 020832 004 NDA CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL SPONGE;TOPICAL 2%;70% (10.5ML) Yes Yes 2000/07/14 2003/08/20 BECTON DICKINSON CO Over-the-counter
CHLORAPREP WITH TINT 020832 005 NDA CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL SPONGE;TOPICAL 2%;70% (10.5ML) Yes Yes 2000/07/14 2006/04/03 BECTON DICKINSON CO Over-the-counter
CHLORAPREP ONE-STEP 020832 006 NDA CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL SPONGE;TOPICAL 2%;70% (26ML) Yes Yes 2000/07/14 2006/11/21 BECTON DICKINSON CO Over-the-counter
CHLORAPREP WITH TINT 020832 007 NDA CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL SPONGE;TOPICAL 2%;70% (3ML) Yes Yes 2000/07/14 2006/10/10 BECTON DICKINSON CO Over-the-counter
CHLORAPREP ONE-STEP 020832 008 NDA CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL SPONGE;TOPICAL 2%;70% (1ML) Yes Yes 2000/07/14 2008/10/23 BECTON DICKINSON CO Over-the-counter
ORAPRED 075117 001 ANDA PREDNISOLONE SODIUM PHOSPHATE SOLUTION;ORAL EQ 15MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No 2000/12/14 2000/12/14 CONCORDIA PHARMS INC Discontinued
CHLORAPREP ONE-STEP SEPP 021555 001 NDA CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL SWAB;TOPICAL 2%;70% (0.67ML) Yes Yes 2002/10/07 2002/10/07 BECTON DICKINSON CO Over-the-counter
CHLORAPREP SINGLE SWABSTICK 021555 002 NDA CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL SWAB;TOPICAL 2%;70% (1.75ML) Yes Yes 2002/10/07 2005/05/10 BECTON DICKINSON CO Over-the-counter
CHLORAPREP TRIPLE SWABSTICK 021555 003 NDA CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL SWAB;TOPICAL 2%;70% (5.25ML) Yes Yes 2002/10/07 2009/06/10 BECTON DICKINSON CO Over-the-counter
ORAPRED ODT 021959 001 NDA PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING;ORAL EQ 10MG BASE Yes No 2006/06/01 2006/06/01 CONCORDIA PHARMS INC Prescription
ORAPRED ODT 021959 002 NDA PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING;ORAL EQ 15MG BASE Yes No 2006/06/01 2006/06/01 CONCORDIA PHARMS INC Prescription
ORAPRED ODT 021959 003 NDA PREDNISOLONE SODIUM PHOSPHATE TABLET, ORALLY DISINTEGRATING;ORAL EQ 30MG BASE Yes Yes 2006/06/01 2006/06/01 CONCORDIA PHARMS INC Prescription
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