| DMF号:
22589 |
项目状态:A |
项目类型:II |
提交日期:2009-02-27 |
| 项目名称:NAFCILLIN FOR INJECTION USP (STERILE) BULK AS MANUFACTURED IN ANDHRA PRADESH, INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
22652 |
项目状态:A |
项目类型:II |
提交日期:2009-03-21 |
| 项目名称:SERTRALINE HYDROCHLORIDE CRYSTALLINE POLYMORPH FORM I AS MANUFACTURED IN ANDHRA PRADESH INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
22754 |
项目状态:A |
项目类型:II |
提交日期:2009-04-30 |
| 项目名称:NAPROXEN USP (NON STERILE DRUG SUBSTANCE) |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
22789 |
项目状态:A |
项目类型:II |
提交日期:2009-05-15 |
| 项目名称:PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE AS MANUFACTURED IN ANDHRA PRADESH INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
22831 |
项目状态:I |
项目类型:V |
提交日期:2009-05-29 |
| 项目名称:STERILE MANUFACTURING FACILITY OF AUROBINDO PHARMA LIMITED UNIT VI LOCATED IN HYDERABAD INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
22832 |
项目状态:A |
项目类型:II |
提交日期:2009-05-30 |
| 项目名称:NAPROXEN SODIUM USP NON STERILE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
22865 |
项目状态:A |
项目类型:II |
提交日期:2009-06-12 |
| 项目名称:PIOGLITAZONE HYDROCHLORIDE USP (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
22970 |
项目状态:A |
项目类型:II |
提交日期:2009-07-18 |
| 项目名称:OMEPRAZOLE MAGNESIUM USP (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
23068 |
项目状态:A |
项目类型:II |
提交日期:2009-08-24 |
| 项目名称:REPAGLINIDE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
23084 |
项目状态:A |
项目类型:II |
提交日期:2009-08-31 |
| 项目名称:IRBESARTAN USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
23174 |
项目状态:A |
项目类型:II |
提交日期:2009-10-09 |
| 项目名称:TORSEMIDE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
23436 |
项目状态:A |
项目类型:II |
提交日期:2009-12-31 |
| 项目名称:CLINDAMYCIN PALMITATE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
23525 |
项目状态:A |
项目类型:II |
提交日期:2010-02-03 |
| 项目名称:OLANZAPINE USP (NON-STERILE DRUG SUBSTANCE) |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
23601 |
项目状态:A |
项目类型:II |
提交日期:2010-02-26 |
| 项目名称:LAMIVUDINE USP (CRYSTALLINE POLYMORPH FORM I) AS MANUFACTURED IN ANDHRA PRADESH INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
23657 |
项目状态:A |
项目类型:II |
提交日期:2010-04-08 |
| 项目名称:FLUVASTATIN SODIUM USP (NON-STERILE DRUG SUBSTANCE) |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
23814 |
项目状态:A |
项目类型:II |
提交日期:2010-05-20 |
| 项目名称:RIZATRIPTAN BENZOATE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA |
| 项目持有人:
AUROBINDO PHARMA 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:
24086 |
项目状态:A |
项目类型:II |
提交日期:2010-08-31 |
| 项目名称:RIVASTIGMINE TARTRATE USP (NON-STERILE DRUG SUBSTANCE) |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
24116 |
项目状态:A |
项目类型:II |
提交日期:2010-09-27 |
| 项目名称:ATORVASTATIN CALCIUM (AMORPHOUS) AS MANUFACTURED IN ANDHRA PRADESH INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
24188 |
项目状态:A |
项目类型:II |
提交日期:2010-09-27 |
| 项目名称:ENTACAPONE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
24285 |
项目状态:A |
项目类型:II |
提交日期:2010-10-29 |
| 项目名称:TRAMADOL HYDROCHLORIDE USP (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
24296 |
项目状态:A |
项目类型:II |
提交日期:2010-11-04 |
| 项目名称:CANDESARTAN CILEXETIL (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
24371 |
项目状态:A |
项目类型:II |
提交日期:2010-11-25 |
| 项目名称:MOXIFLOXACIN HYDROCHLORIDE USP (NON STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
24520 |
项目状态:A |
项目类型:II |
提交日期:2011-01-17 |
| 项目名称:NEVIRAPINE ANHYDROUS USP (PROCESS II) |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
24544 |
项目状态:A |
项目类型:II |
提交日期:2011-03-02 |
| 项目名称:VALSARTAN USP (PROCESS II) AS MANUFACTURED IN ANDHRA PRADESH, INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
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