| DMF号:
20211 |
项目状态:A |
项目类型:II |
提交日期:2007-01-16 |
| 项目名称:AMPICILLIN SODIUM USP (STERILE) BULK AS MANUFACTURED IN ANDHRA PRADESH INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
20300 |
项目状态:A |
项目类型:II |
提交日期:2007-02-22 |
| 项目名称:AMPICILLIN AND SULBACTAM FOR INJECTION USP (STERILE BULK MIXTURE 2:1) AS MANUFACTURED IN ANDHRA PRADESH INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
20307 |
项目状态:A |
项目类型:II |
提交日期:2007-02-24 |
| 项目名称:ALFUZOSIN HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
20316 |
项目状态:A |
项目类型:II |
提交日期:2007-02-19 |
| 项目名称:CEFOXITIN ACID (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) AS MANUFACTURED IN ANDHRA PRADESH INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
20393 |
项目状态:A |
项目类型:II |
提交日期:2007-03-29 |
| 项目名称:IBANDRONATE SODIUM (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
20629 |
项目状态:A |
项目类型:II |
提交日期:2007-06-22 |
| 项目名称:ROSUVASTATIN CALCIUM (NON-STERILE DRUG SUBSTANCE) |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
20708 |
项目状态:A |
项目类型:II |
提交日期:2007-07-18 |
| 项目名称:EMTRICITABINE (NON-STERILE) DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
20766 |
项目状态:A |
项目类型:II |
提交日期:2007-07-31 |
| 项目名称:GLYCOPYRROLATE USP, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA. |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
20870 |
项目状态:A |
项目类型:II |
提交日期:2007-09-17 |
| 项目名称:DIDANOSINE USP, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
20890 |
项目状态:A |
项目类型:II |
提交日期:2007-09-24 |
| 项目名称:FELODIPINE USP, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
20909 |
项目状态:A |
项目类型:II |
提交日期:2007-09-29 |
| 项目名称:DONEPEZIL HYDROCHLORIDE USP, NON-STERILE DRUG SUBSTANCE AS MANUFACTURED IN ANDHRA PRADESH, INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
21012 |
项目状态:A |
项目类型:II |
提交日期:2007-10-29 |
| 项目名称:Ziprasidone Hydrochloride USP (Non-Sterile Drug Substance) as manufactured in Andhra Pradesh, India |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
21096 |
项目状态:A |
项目类型:II |
提交日期:2007-11-23 |
| 项目名称:Tenofovir Disoproxil Fumarate (Non-Sterile Drug Substance) as manufactured in Andhra Pradesh, India |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
21121 |
项目状态:A |
项目类型:II |
提交日期:2007-12-06 |
| 项目名称:Risedronate Sodium Hemipentahydrate USP (Non-Sterile Drug Substance) as manufactured in Andhra Pradesh, India |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
21223 |
项目状态:A |
项目类型:II |
提交日期:2007-12-31 |
| 项目名称:OMEPRAZOLE USP (NON-STERILE DRUG SUBSTANCE) |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
21329 |
项目状态:I |
项目类型:II |
提交日期:2008-01-31 |
| 项目名称:CEFOXITIN SODIUM USP (STERILE BULK) AS MANUFACTURED IN ANDHRA PRADESH, INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
21688 |
项目状态:A |
项目类型:II |
提交日期:2008-06-07 |
| 项目名称:VALACYCLOVIR HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
21767 |
项目状态:A |
项目类型:II |
提交日期:2008-06-27 |
| 项目名称:DULOXETINE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
21845 |
项目状态:A |
项目类型:II |
提交日期:2008-07-30 |
| 项目名称:VALSARTAN USP (NON-STERILE DRUG SUBSTANCE) AS MANUFACTURED IN ANDHRA PRADESH, INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
21934 |
项目状态:A |
项目类型:II |
提交日期:2008-09-02 |
| 项目名称:GALANTAMINE HBR USP (NS DS) |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
22204 |
项目状态:A |
项目类型:II |
提交日期:2008-11-19 |
| 项目名称:FAMCICLOVIR USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
22265 |
项目状态:A |
项目类型:II |
提交日期:2008-12-06 |
| 项目名称:LEVOFLOXACIN USP (NON-STERILE DRUG SUBSTANCE) |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
22464 |
项目状态:A |
项目类型:II |
提交日期:2009-01-23 |
| 项目名称:OXACILLIN FOR INJECTION USP (STERILE BULK) AS MANUFACTURED IN ANDHRA PRADESH, INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
22473 |
项目状态:A |
项目类型:II |
提交日期:2009-01-29 |
| 项目名称:NAFCILLIN SODIUM (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) MANUFACTURED IN ANDHRA PRADESH, INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
| DMF号:
22477 |
项目状态:A |
项目类型:V |
提交日期:2009-01-22 |
| 项目名称:STERILE MANUFACTURING FACILITY OF AUROBINDO PHARMA LIMITED, UNIT-V AT HYDERABAD, INDIA |
| 项目持有人:
AUROBINDO PHARMA LTD
|
|
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