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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Suzhou Lixin Pharmaceutical

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01 Capecitabine (1)

02 Dacarbazine (1)

03 Hydrochlorothiazide (1)

04 Idebenone (1)

05 Indapamide (1)

06 Nilotinib (1)

07 Pemetrexed Disodium (2)

08 Temozolomide (1)

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01 Active (3)

02 Inactive (1)

03 Blank (5)

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01 Valid (8)

02 Blank (1)

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01 Blank (9)

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01 Blank (9)

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USDMF

Found USDMF

31693
Active
NILOTINIB HYDROCHLORIDE MONOHYDRATE
2017-04-14
CEP/COS

Found CEP/COS

R0-CEP 2021-133 - Rev 00
Valid
Nilotinib hydrochloride monohydrate
2023-07-21
Japanese DMF

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Written Confirmation

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Application Number
31693
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
NILOTINIB HYDROCHLORIDE MONOHYDRATE
Nilotinib hydrochloride monohydrate
Issue/Submission Date
2017-04-14
2023-07-21
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USDMF

Found USDMF

25640
Active
PEMETREXED DISODIUM (NON STERILE)
2011-12-27
CEP/COS

Found CEP/COS

R0-CEP 2021-072 - Rev 00
Valid
Pemetrexed disodium 2.5-hydrate
2022-07-08
Japanese DMF

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Written Confirmation

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Application Number
25640
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
PEMETREXED DISODIUM (NON STERILE)
Pemetrexed disodium 2.5-hydrate
Issue/Submission Date
2011-12-27
2022-07-08
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USDMF

Caution USDMF

21181
Inactive
HYDROCHLOROTHIAZIDE
2007-12-31
CEP/COS

Found CEP/COS

CEP 2012-250 - Rev 02
Valid
Hydrochlorothiazide
2023-09-20
Japanese DMF

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Written Confirmation

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Application Number
21181
Status
Inactive
Fees Unpaid
N/A
Valid
 
Filing Details
HYDROCHLOROTHIAZIDE
Hydrochlorothiazide
Issue/Submission Date
2007-12-31
2023-09-20
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USDMF

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CEP/COS

Found CEP/COS

R0-CEP 2021-316 - Rev 00
Valid
Capecitabine
2022-10-19
Japanese DMF

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Application Number
Status
Valid
 
Filing Details
Capecitabine
Issue/Submission Date
2022-10-19
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2010-315 - Rev 02
Valid
Dacarbazine
2023-02-17
Japanese DMF

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Application Number
Status
Valid
 
Filing Details
Dacarbazine
Issue/Submission Date
2023-02-17
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USDMF

Found USDMF

32079
Active
IDEBENONE (NON-STERILE)
2017-08-28
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
32079
Status
Active
Fees Unpaid
N/A
 
Filing Details
IDEBENONE (NON-STERILE)
Issue/Submission Date
2017-08-28
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2012-182 - Rev 01
Valid
Indapamide
2023-02-06
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Indapamide
Issue/Submission Date
2023-02-06
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R0-CEP 2020-398 - Rev 00
Valid
Pemetrexed disodium heptahydrate
2022-01-03
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Pemetrexed disodium heptahydrate
Issue/Submission Date
2022-01-03
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USDMF

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CEP/COS

Found CEP/COS

R0-CEP 2020-359 - Rev 00
Valid
Temozolomide
2022-04-26
Japanese DMF

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Application Number
Status
Valid
 
Filing Details
Temozolomide
Issue/Submission Date
2022-04-26
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