| DMF号:
11806 |
项目状态:I |
项目类型:I |
提交日期:1996-01-15 |
| 项目名称:MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF MODAFINIL DRUG SUBSTANCE IN MITRY-MORY MITRY-MORY CEDEX FRANCE. |
| 项目持有人:
ORSYMONDE
|
|
| DMF号:
11970 |
项目状态:A |
项目类型:II |
提交日期:1996-05-15 |
| 项目名称:MODAFINIL DRUG SUBSTANCE MANUFACTURED IN MITRY-MORY CEDEX, FRANCE AND BY ISOCHEM IN GENNEVILLIERS CEDEX, FRANCE. |
| 项目持有人:
CEPHALON FRANCE
|
|
| DMF号:
16140 |
项目状态:A |
项目类型:II |
提交日期:2002-09-19 |
| 项目名称:MODAFINIL AS MANUFACTURED IN BE'ER SHEVA, ISRAEL. |
| 项目持有人:
PERRIGO API LTD
|
|
| DMF号:
16250 |
项目状态:A |
项目类型:II |
提交日期:2002-11-19 |
| 项目名称:MODAFINIL AS MANUFACTURED IN CARONNO PERTUSELLA, ITALY. |
| 项目持有人:
DIPHARMA FRANCIS SRL
|
|
| DMF号:
16306 |
项目状态:A |
项目类型:II |
提交日期:2002-12-12 |
| 项目名称:MODAFINIL USP AS MANUFACTURED IN TELANGANA, INDIA. |
| 项目持有人:
MYLAN LABORATORIES LTD
|
|
|
|
|
|
|
|
|
|
| DMF号:
18062 |
项目状态:A |
项目类型:II |
提交日期:2005-02-03 |
| 项目名称:MODAFINIL AS MANUFACTURED IN BERGAMO, ITALY. |
| 项目持有人:
FLAMMA SPA
|
|
| DMF号:
18107 |
项目状态:A |
项目类型:II |
提交日期:2005-02-21 |
| 项目名称:ARMODAFINIL DRUG SUBSTANCE AS MANUFACTURED IN CO. WICKLOW, IRELAND. |
| 项目持有人:
SIGMA ALDRICH IRELAND LTD
|
|
| DMF号:
18109 |
项目状态:A |
项目类型:II |
提交日期:2005-02-18 |
| 项目名称:ARMODAFINIL AS MANUFACTURED IN POMPEY, FRANCE. |
| 项目持有人:
NOVASEP PROCESS SAS
|
|
|
|
|
|
| DMF号:
19685 |
项目状态:A |
项目类型:II |
提交日期:2006-08-15 |
| 项目名称:ARMODAFINIL DRUG SUBSTANCE AS MANUFACTURED IN NYKOEBING S, DENMARK. |
| 项目持有人:
CEPHALON INC
|
|
| DMF号:
21200 |
项目状态:A |
项目类型:II |
提交日期:2007-12-19 |
| 项目名称:ARMODAFINIL AS MANUFACTURED IN TELANGANA, INDIA |
| 项目持有人:
MYLAN LABORATORIES LTD
|
|
| DMF号:
22957 |
项目状态:A |
项目类型:II |
提交日期:2009-07-17 |
| 项目名称:ARMODAFINIL AS MANUFACTURED BY ASSIA CHEMICAL INDUSTRIES LTD IN BEER SHEVA ISRAEL FOR TEVA PHARMACEUTICAL IND LTD |
| 项目持有人:
TEVA PHARMACEUTICAL INDUSTRIES LTD
|
|
| DMF号:
22983 |
项目状态:A |
项目类型:II |
提交日期:2009-07-24 |
| 项目名称:ARMODAFINIL (NON STERILE BULK DRUG SUBSTANCE) AS MANUFACTURED IN TAMIL NADU INDIA |
| 项目持有人:
ACTAVIS GROUP PTC EHF
|
|
| DMF号:
23134 |
项目状态:A |
项目类型:II |
提交日期:2009-10-27 |
| 项目名称:ARMODAFINIL |
| 项目持有人:
LUPIN LTD
|
|
| DMF号:
23146 |
项目状态:A |
项目类型:II |
提交日期:2009-10-02 |
| 项目名称:(R)-MODAFINIL AS MANUFACTURED IN MARSA MALTA |
| 项目持有人:
AMINO CHEMICALS LTD
|
|
| DMF号:
23898 |
项目状态:A |
项目类型:II |
提交日期:2010-06-29 |
| 项目名称:MODAFINIL USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
24945 |
项目状态:A |
项目类型:II |
提交日期:2011-06-01 |
| 项目名称:ARMODAFINIL AS MFG IN GUJARAT INDIA |
| 项目持有人:
UNIMARK REMEDIES LTD
|
|
|
|
| DMF号:
27302 |
项目状态:A |
项目类型:II |
提交日期:2013-07-29 |
| 项目名称:ARMODAFINIL AS MANUFACTURED IN ANDHRA PRADESH, INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
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