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Athena Athena

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Pliva Hrvatska D.o.o

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01 Azithromycin (1)

02 Azithromycin Dihydrate (1)

03 Carboplatin (2)

04 Chlorhexidine (1)

05 Chlorhexidine Gluconate (1)

06 Chlorothiazide (1)

07 Chlorpropamide (1)

08 Dacarbazine (1)

09 Donepezil (1)

10 Eszopiclone (1)

11 Etodolac (1)

12 Glutethimide (1)

13 Hydrochlorothiazide (1)

14 Imatinib Mesylate (1)

15 Irinotecan Hydrochloride (1)

16 Ketoprofen (1)

17 Meclizine Hydrochloride (1)

18 Mesalazine (1)

19 Metoprolol Tartrate (1)

20 Omeprazole (1)

21 Oxaliplatin (1)

22 Oxytetracycline Dihydrate (1)

23 Oxytetracycline Hydrochloride (1)

24 Pemoline (1)

25 Sugammadex Sodium (1)

26 Sulfisoxazole (1)

27 Blank (2)

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01 Active (2)

02 Inactive (17)

03 Blank (10)

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01 Valid (2)

02 Withdrawn by Holder (3)

03 Blank (24)

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01 218MF10412 (1)

02 219MF10049 (1)

03 222MF10184 (1)

04 224MF10188 (1)

05 225MF10127 (1)

06 227MF10244 (1)

07 228MF10074 (1)

08 229MF10218 (1)

09 305MF10026 (1)

10 Blank (20)

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01 Blank (29)

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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2010-131 - Rev 02
Valid
Azithromycin, Monohydrate
2021-10-27
Japanese DMF

Found JDMF

219MF10049
Azithromycin hydrate at Prilaz baru...
2007-02-13
Written Confirmation

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Application Number
219MF10049
Status
Valid
 
Filing Details
Azithromycin, Monohydrate
Azithromycin hydrate at Prilaz baru...
Issue/Submission Date
2021-10-27
2007-02-13
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USDMF

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19594
Active
OXALIPLATIN
2006-07-11
CEP/COS

Caution CEP/COS

R0-CEP 2008-082 - Rev 00
Withdrawn by Holder
Oxaliplatin
2009-10-20
Japanese DMF

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Written Confirmation

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Application Number
19594
Status
Active
Fees Paid
N/A
Withdrawn by Holder
 
Filing Details
OXALIPLATIN
Oxaliplatin
Issue/Submission Date
2006-07-11
2009-10-20
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2007-072 - Rev 02
Valid
Azithromycin, Dihydrate
2021-10-25
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Azithromycin, Dihydrate
Issue/Submission Date
2021-10-25
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USDMF

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16280
Inactive
CARBOPLATIN
2002-12-02
CEP/COS

Caution CEP/COS

R0-CEP 2005-157 - Rev 00
Withdrawn by Holder
Carboplatin
2007-10-02
Japanese DMF

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Written Confirmation

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Application Number
16280
Status
Inactive
Fees Paid
N/A
Withdrawn by Holder
 
Filing Details
CARBOPLATIN
Carboplatin
Issue/Submission Date
2002-12-02
2007-10-02
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USDMF

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CEP/COS

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Japanese DMF

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218MF10412
Carboplatin at Kara(´)sek 1,621 33...
2006-04-14
Written Confirmation

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Application Number
218MF10412
Status
 
Filing Details
Carboplatin at Kara(´)sek 1,621 33...
Issue/Submission Date
2006-04-14
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USDMF

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CEP/COS

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Japanese DMF

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222MF10184
Donepezil hydrochloride \"Teva\" at...
2010-06-28
Written Confirmation

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Application Number
222MF10184
Status
 
Filing Details
Donepezil hydrochloride \"Teva\" at...
Issue/Submission Date
2010-06-28
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USDMF

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CEP/COS

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Japanese DMF

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228MF10074
Eszopiclone \"Teva / PLIVA\" at Pri...
2016-03-24
Written Confirmation

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Application Number
228MF10074
Status
 
Filing Details
Eszopiclone \"Teva / PLIVA\" at Pri...
Issue/Submission Date
2016-03-24
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USDMF

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CEP/COS

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Japanese DMF

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227MF10244
Etodolac \"Teva / PLIVA2\" at Prila...
2015-10-07
Written Confirmation

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Application Number
227MF10244
Status
 
Filing Details
Etodolac \"Teva / PLIVA2\" at Prila...
Issue/Submission Date
2015-10-07
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USDMF

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CEP/COS

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Japanese DMF

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229MF10218
Hydrochlorothiazide \"Teva / Pliva\...
2017-12-12
Written Confirmation

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Application Number
229MF10218
Status
 
Filing Details
Hydrochlorothiazide \"Teva / Pliva\...
Issue/Submission Date
2017-12-12
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USDMF

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CEP/COS

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Japanese DMF

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224MF10188
Imatinib mesylate \"Teva\" at Prila...
2012-09-03
Written Confirmation

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Application Number
224MF10188
Status
 
Filing Details
Imatinib mesylate \"Teva\" at Prila...
Issue/Submission Date
2012-09-03
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