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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Sintenovo, S.a. De C.v.

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01 Apixaban (1)

02 Atenolol (1)

03 Cetirizine Dihydrochloride (1)

04 Esomeprazole Sodium (1)

05 Montelukast Sodium (1)

06 Olmesartan Medoxomil (1)

07 Omeprazole Magnesium (1)

08 Paliperidone (1)

09 Rabeprazole (1)

10 Sitagliptin Phosphate (1)

11 Tofacitinib Citrate (1)

12 Blank (1)

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01 Active (1)

02 Inactive (8)

03 Blank (3)

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01 Valid (2)

02 Withdrawn by Holder (1)

03 Blank (9)

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01 Blank (12)

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01 Blank (12)

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USDMF

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CEP/COS

Found CEP/COS

R0-CEP 2019-333 - Rev 00
Valid
Esomeprazole sodium
2020-12-03
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Esomeprazole sodium
Issue/Submission Date
2020-12-03
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2009-163 - Rev 02
Valid
Omeprazole magnesium
2020-11-12
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Omeprazole magnesium
Issue/Submission Date
2020-11-12
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USDMF

Found USDMF

26254
Active
PALIPERIDONE
2012-07-27
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
26254
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
PALIPERIDONE
Issue/Submission Date
2012-07-27
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USDMF

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30653
Inactive
APIXABAN
2016-06-28
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
30653
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
APIXABAN
Issue/Submission Date
2016-06-28
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USDMF

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7586
Inactive
ATENOLOL
1988-07-12
CEP/COS

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Japanese DMF

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Application Number
7586
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
ATENOLOL
Issue/Submission Date
1988-07-12
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USDMF

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19432
Inactive
CETIRIZINE DIHYDROCHLORIDE
2006-05-15
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
19432
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
CETIRIZINE DIHYDROCHLORIDE
Issue/Submission Date
2006-05-15
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USDMF

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24747
Inactive
MONTELUKAST SODIUM
2011-03-10
CEP/COS

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Japanese DMF

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Application Number
24747
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
MONTELUKAST SODIUM
Issue/Submission Date
2011-03-10
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USDMF

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CEP/COS

Caution CEP/COS

R0-CEP 2012-238 - Rev 01
Withdrawn by Holder
Olmesartan medoxomil
2015-04-22
Japanese DMF

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Written Confirmation

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Application Number
Status
Withdrawn by Holder
 
Filing Details
Olmesartan medoxomil
Issue/Submission Date
2015-04-22
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USDMF

Caution USDMF

23907
Inactive
RABEPRAZOLE SODIUM
2010-06-08
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
23907
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
RABEPRAZOLE SODIUM
Issue/Submission Date
2010-06-08
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USDMF

Caution USDMF

28908
Inactive
SITAGLIPTIN PHOSPHATE MONOHYDRATE
2015-05-15
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
28908
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
SITAGLIPTIN PHOSPHATE MONOHYDRATE
Issue/Submission Date
2015-05-15
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