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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Shandong Keyuan Pharmaceutical Co., Ltd.

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01 Gliclazide (1)

02 Isosorbide (1)

03 Isosorbide Mononitrate (1)

04 Metformin (2)

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01 Active (1)

02 Inactive (2)

03 Blank (2)

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01 Valid (3)

02 Blank (2)

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01 222MF10034 (1)

02 229MF10189 (1)

03 Blank (3)

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01 Blank (5)

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USDMF

Caution USDMF

21809
Inactive
DILUTED ISOSORBIDE MONONITRATE (DRU...
2008-06-18
CEP/COS

Found CEP/COS

R1-CEP 2008-112 - Rev 00
Valid
Isosorbide mononitrate, diluted, 80...
2014-10-10
Japanese DMF

Found JDMF

229MF10189
Isosorbide Mononitrate 70% / Lactos...
2017-10-26
Written Confirmation

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Application Number
21809
229MF10189
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
DILUTED ISOSORBIDE MONONITRATE (DRU...
Isosorbide mononitrate, diluted, 80...
Isosorbide Mononitrate 70% / Lactos...
Issue/Submission Date
2008-06-18
2014-10-10
2017-10-26
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USDMF

Caution USDMF

24604
Inactive
METFORMIN HYDROCHLORIDE
2011-01-17
CEP/COS

Found CEP/COS

R0-CEP 2019-288 - Rev 00
Valid
Metformin Hydrochloride
2022-06-17
Japanese DMF

Found JDMF

222MF10034
Metformin Hydrochloride at Keyuan S...
2010-01-28
Written Confirmation

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Application Number
24604
222MF10034
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
METFORMIN HYDROCHLORIDE
Metformin Hydrochloride
Metformin Hydrochloride at Keyuan S...
Issue/Submission Date
2011-01-17
2022-06-17
2010-01-28
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2006-007 - Rev 01
Valid
Gliclazide
2013-05-29
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Gliclazide
Issue/Submission Date
2013-05-29
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USDMF

Found USDMF

33876
Active
METFORMIN HYDROCHLORIDE
2019-05-16
CEP/COS

Close CEP/COS

Japanese DMF

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Written Confirmation

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Application Number
33876
Status
Active
Fees Paid
Reviewed
 
Filing Details
METFORMIN HYDROCHLORIDE
Issue/Submission Date
2019-05-16
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USDMF

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CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

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Application Number
Status
 
Filing Details
Issue/Submission Date
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