| DMF号:
12797 |
项目状态:A |
项目类型:II |
提交日期:1997-12-22 |
| 项目名称:HIRULOG (BIVALIRUDIN)- ACTIVE PHARMACEUTICAL INGREDIENT |
| 项目持有人:
LONZA AG
|
|
| DMF号:
20853 |
项目状态:A |
项目类型:II |
提交日期:2007-09-14 |
| 项目名称:BIVALIRUDIN, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED BY AMBIOPHARM INC IN AUGUSTA, SC AND SHANGHAI AMBIOPHARM INC. IN SHANGHAI, CHINA FOR AMBIOPHARM INC |
| 项目持有人:
AMBIOPHARM INC
|
|
| DMF号:
20863 |
项目状态:A |
项目类型:II |
提交日期:2007-09-18 |
| 项目名称:BIVALIRUDIN AS MANUFACTURED BY PLANTEX LTD IN NETANYA, ISRAEL FOR TEVA PHARMACEUTICAL INDUSTRIES LTD |
| 项目持有人:
TEVA PHARMACEUTICAL INDUSTRIES LTD
|
|
| DMF号:
23656 |
项目状态:A |
项目类型:II |
提交日期:2010-03-23 |
| 项目名称:BIVALIRUDIN AS MANUFACTURED IN ANDHRA PRADESH, INDIA |
| 项目持有人:
DR REDDYS LABORATORIES LTD
|
|
| DMF号:
24257 |
项目状态:A |
项目类型:II |
提交日期:2010-09-15 |
| 项目名称:BIVALIRUDIN AS MANUFACTURED IN ZHEJIANG, P.R. CHINA FOR ALP PHARM BEIJING CO LTD |
| 项目持有人:
ALP PHARM BEIJING CO LTD
|
|
|
|
| DMF号:
25165 |
项目状态:A |
项目类型:II |
提交日期:2011-04-14 |
| 项目名称:BIVALIRUDIN, NON-STERILE BULK DRUG SUBSTANCE AS MANUFACTURED IN GUANGDONG, P. R. CHINA |
| 项目持有人:
HYBIO PHARMACEUTICAL CO LTD
|
|
|
|
|
|
| DMF号:
28912 |
项目状态:A |
项目类型:II |
提交日期:2014-12-05 |
| 项目名称:BIVALIRUDIN (TM-001-2G) |
| 项目持有人:
LONZA AG
|
|
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