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Athena Athena

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Synthon Pharmaceuticals, Inc

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01 Anastrozole (1)

02 Aripiprazole (1)

03 Axitinib (1)

04 Bicalutamide (1)

05 Enzalutamide (1)

06 Everolimus (1)

07 Exemestane (1)

08 Fingolimod Hydrochloride (1)

09 Flumazenil (1)

10 Gefitinib (1)

11 Lenalidomide (1)

12 Letrozole (1)

13 Mirabegron (1)

14 Ozanimod (1)

15 Palbociclib (1)

16 Pemetrexed Disodium (1)

17 Pomalidomide (1)

18 Pramipexole Dihydrochloride (1)

19 Risperidone (1)

20 Sugammadex Sodium (1)

21 Tamsulosin (1)

22 Valsartan (1)

23 Zolpidem Tartrate (1)

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01 Active (9)

02 Blank (14)

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01 Expired (1)

02 Valid (12)

03 Withdrawn by Holder (1)

04 Blank (9)

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01 227MF10174 (1)

02 229MF10200 (1)

03 305MF10012 (1)

04 Blank (20)

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01 Blank (23)

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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2015-253 - Rev 00
Valid
Flumazenil
2022-05-24
Japanese DMF

Found JDMF

227MF10174
Flumazenil at Brnenska 32, 678 17 B...
2015-06-26
Written Confirmation

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Application Number
227MF10174
Status
Valid
 
Filing Details
Flumazenil
Flumazenil at Brnenska 32, 678 17 B...
Issue/Submission Date
2022-05-24
2015-06-26
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2016-154 - Rev 00
Valid
Gefitinib
2022-06-07
Japanese DMF

Found JDMF

229MF10200
Gefitinib at Brnenska 32/cp. 597 67...
2017-11-14
Written Confirmation

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Application Number
229MF10200
Status
Valid
 
Filing Details
Gefitinib
Gefitinib at Brnenska 32/cp. 597 67...
Issue/Submission Date
2022-06-07
2017-11-14
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USDMF

Found USDMF

33987
Active
SUGAMMADEX OCTASODIUM
2019-07-10
CEP/COS

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Japanese DMF

Found JDMF

305MF10012
Sugammadex octasodium at Brnenska 3...
2023-02-02
Written Confirmation

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Application Number
33987
305MF10012
Status
Active
Fees Paid
Reviewed
 
Filing Details
SUGAMMADEX OCTASODIUM
Sugammadex octasodium at Brnenska 3...
Issue/Submission Date
2019-07-10
2023-02-02
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2015-254 - Rev 00
Valid
Anastrozole
2022-03-21
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Anastrozole
Issue/Submission Date
2022-03-21
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USDMF

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CEP/COS

Found CEP/COS

R0-CEP 2019-191 - Rev 00
Valid
Aripiprazole
2020-09-25
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Aripiprazole
Issue/Submission Date
2020-09-25
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USDMF

Found USDMF

37971
Active
AXITINIB
2023-02-02
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
37971
Status
Active
Fees Paid
Reviewed
 
Filing Details
AXITINIB
Issue/Submission Date
2023-02-02
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2012-153 - Rev 01
Valid
Bicalutamide
2021-09-29
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Bicalutamide
Issue/Submission Date
2021-09-29
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USDMF

Found USDMF

36447
Active
ENZALUTAMIDE
2021-10-29
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
36447
Status
Active
Fees Paid
Reviewed
 
Filing Details
ENZALUTAMIDE
Issue/Submission Date
2021-10-29
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USDMF

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CEP/COS

Found CEP/COS

CEP 2021-260 - Rev 01
Valid
Everolimus, BHT 2.0%
2024-02-23
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Everolimus, BHT 2.0%
Issue/Submission Date
2024-02-23
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USDMF

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CEP/COS

Found CEP/COS

CEP 2022-424 - Rev 00
Valid
Exemestane
2023-10-06
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Exemestane
Issue/Submission Date
2023-10-06
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