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

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01 Amlodipine Besylate (1)

02 Atorvastatin (2)

03 Azilsartan (1)

04 Bacampicillin (1)

05 Blonanserin (1)

06 Cefaclor (1)

07 Cefixime (1)

08 Cefmetazole Sodium (2)

09 Cefoperazone Sodium (1)

10 Cefotaxime (1)

11 Cefotiam Hydrochloride (2)

12 Ceftazidime (1)

13 Ceftriaxone (2)

14 Citric Acid (1)

15 Clarithromycin (2)

16 Clopidogrel (1)

17 Diquafosol Sodium (1)

18 Doxifluridine (1)

19 Entacapone (2)

20 Entecavir (1)

21 Imatinib Mesylate (1)

22 Imidapril Hydrochloride (1)

23 Lenalidomide (1)

24 Luliconazole (1)

25 Meropenem (1)

26 Montelukast Sodium (3)

27 Nateglinide (1)

28 Olanzapine (1)

29 Olmesartan Medoxomil (1)

30 Oteracil Potassium (1)

31 Palonosetron (1)

32 Pitavastatin (2)

33 Pranlukast Hydrate (1)

34 Raloxifene Hydrochloride (1)

35 Rosuvastatin Calcium (1)

36 Simvastatin (1)

37 Solifenacin Succinate (1)

38 Sulbactam Sodium (2)

39 Telmisartan (1)

40 Tiotropium Bromide (1)

41 Blank (2)

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01 Active (1)

02 Inactive (13)

03 Blank (38)

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01 Expired (1)

02 Valid (3)

03 Withdrawn by Holder (6)

04 Blank (42)

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01 217MF10577 (1)

02 218MF10710 (1)

03 218MF10896 (1)

04 219MF10078 (1)

05 219MF10293 (1)

06 220MF10091 (1)

07 220MF10215 (1)

08 221MF10194 (1)

09 222MF10201 (1)

10 223MF10104 (1)

11 224MF10034 (1)

12 224MF10051 (1)

13 224MF10092 (1)

14 224MF10167 (1)

15 224MF10170 (1)

16 225MF10124 (1)

17 225MF10166 (1)

18 225MF10215 (1)

19 225MF10229 (1)

20 226MF10111 (1)

21 226MF10193 (1)

22 227MF10041 (1)

23 227MF10048 (1)

24 227MF10220 (1)

25 227MF10222 (1)

26 228MF10035 (1)

27 229MF10029 (1)

28 229MF10212 (1)

29 230MF10153 (1)

30 301MF10112 (1)

31 302MF10042 (1)

32 302MF10121 (1)

33 303MF10001 (1)

34 303MF10008 (1)

35 303MF10133 (1)

36 303MF10160 (1)

37 304MF10008 (1)

38 304MF10015 (1)

39 304MF10079 (1)

40 304MF10089 (1)

41 304MF10110 (1)

42 306MF10009 (1)

43 Blank (10)

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01 Blank (52)

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USDMF

Caution USDMF

20077
Inactive
CEFTRIAXONE SODIUM STERILE
2006-11-09
CEP/COS

Found CEP/COS

R1-CEP 2006-305 - Rev 03
Valid
Ceftriaxone sodium, Sterile
2022-07-15
Japanese DMF

Found JDMF

220MF10091
Ceftriaxone sodium hydrate at 174, ...
2008-03-28
Written Confirmation

Close WC

Application Number
20077
220MF10091
Status
Inactive
Fees Unpaid
N/A
Valid
 
Filing Details
CEFTRIAXONE SODIUM STERILE
Ceftriaxone sodium, Sterile
Ceftriaxone sodium hydrate at 174, ...
Issue/Submission Date
2006-11-09
2022-07-15
2008-03-28
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USDMF

Caution USDMF

27033
Inactive
CEFIXIME BULK
2013-04-03
CEP/COS

Caution CEP/COS

R0-CEP 2014-217 - Rev 00
Withdrawn by Holder
Cefixime
2016-12-02
Japanese DMF

Found JDMF

224MF10092
Cefixime hydrate at 174, Sirok-ro, ...
2012-04-25
Written Confirmation

Close WC

Application Number
27033
224MF10092
Status
Inactive
Fees Unpaid
N/A
Withdrawn by Holder
 
Filing Details
CEFIXIME BULK
Cefixime
Cefixime hydrate at 174, Sirok-ro, ...
Issue/Submission Date
2013-04-03
2016-12-02
2012-04-25
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USDMF

Caution USDMF

24793
Inactive
CEFOTAXIME SODIUM, STERILE API
2011-03-15
CEP/COS

Found CEP/COS

R1-CEP 2006-224 - Rev 04
Valid
Cefotaxime sodium, Sterile
2022-07-12
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
24793
Status
Inactive
Fees Unpaid
N/A
Valid
 
Filing Details
CEFOTAXIME SODIUM, STERILE API
Cefotaxime sodium, Sterile
Issue/Submission Date
2011-03-15
2022-07-12
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USDMF

Close USDMF

CEP/COS

Caution CEP/COS

R0-CEP 2015-168 - Rev 00
Withdrawn by Holder
Entacapone
2016-11-04
Japanese DMF

Found JDMF

302MF10042
Entacapone at 174, Sirok-ro, Asan-...
2020-04-02
Written Confirmation

Close WC

Application Number
302MF10042
Status
Withdrawn by Holder
 
Filing Details
Entacapone
Entacapone at 174, Sirok-ro, Asan-...
Issue/Submission Date
2016-11-04
2020-04-02
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USDMF

Caution USDMF

27066
Inactive
ENTECAVIR
2013-04-05
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

225MF10215
Entecavir hydrate at 174, Sirok-ro,...
2013-12-03
Written Confirmation

Close WC

Application Number
27066
225MF10215
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
ENTECAVIR
Entecavir hydrate at 174, Sirok-ro,...
Issue/Submission Date
2013-04-05
2013-12-03
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USDMF

Caution USDMF

28511
Inactive
IMATINIB MESYLATE
2014-07-25
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

224MF10167
Imatinib mesylate at 174, Sirok-ro,...
2012-08-16
Written Confirmation

Close WC

Application Number
28511
224MF10167
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
IMATINIB MESYLATE
Imatinib mesylate at 174, Sirok-ro,...
Issue/Submission Date
2014-07-25
2012-08-16
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USDMF

Caution USDMF

33613
Inactive
PALONOSETRON HYDROCHLORIDE
2019-04-02
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

304MF10110
Palonosetron Hydrochloride at 174, ...
2022-08-03
Written Confirmation

Close WC

Application Number
33613
304MF10110
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
PALONOSETRON HYDROCHLORIDE
Palonosetron Hydrochloride at 174, ...
Issue/Submission Date
2019-04-02
2022-08-03
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USDMF

Close USDMF

CEP/COS

Caution CEP/COS

R0-CEP 2015-174 - Rev 00
Withdrawn by Holder
Raloxifene hydrochloride
2016-11-02
Japanese DMF

Found JDMF

227MF10048
Raloxifene hydrochloride hydrate at...
2015-02-09
Written Confirmation

Close WC

Application Number
227MF10048
Status
Withdrawn by Holder
 
Filing Details
Raloxifene hydrochloride
Raloxifene hydrochloride hydrate at...
Issue/Submission Date
2016-11-02
2015-02-09
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

225MF10124
Amlodipine besylate (production onl...
2013-06-19
Written Confirmation

Close WC

Application Number
225MF10124
Status
 
Filing Details
Amlodipine besylate (production onl...
Issue/Submission Date
2013-06-19
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

304MF10015
Atorvastatin Calcium Hydrate (KBP) ...
2022-01-20
Written Confirmation

Close WC

Application Number
304MF10015
Status
 
Filing Details
Atorvastatin Calcium Hydrate (KBP) ...
Issue/Submission Date
2022-01-20
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