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

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Daewoong Pharmaceutical
korearepublicofnew Flag
Country
Country
South Korea
Address
Address
Bongeunsa-ro114-gil 12, Gangnam-gu, Seoul, Korea
Telephone
Telephone
822 550 8128
Twitter
Twitter

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USDMF

Found USDMF

25536
Active
URSODIOL USP (PROCESS I)
2011-11-16
CEP/COS

Found CEP/COS

R1-CEP 2012-157 - Rev 00
Valid
Ursodeoxycholic acid, Process II
2018-06-19
Japanese DMF

Found JDMF

304MF10016
Ursodeoxocholic acid at 12, BONGEUN...
2022-01-20
Written Confirmation

Close WC

Application Number
25536
304MF10016
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
URSODIOL USP (PROCESS I)
Ursodeoxycholic acid, Process II
Ursodeoxocholic acid at 12, BONGEUN...
Issue/Submission Date
2011-11-16
2018-06-19
2022-01-20
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USDMF

Found USDMF

28994
Active
URSODIOL USP (PROCESS IV)
2015-02-10
CEP/COS

Found CEP/COS

R0-CEP 2022-479 - Rev 00
Valid
Ursodeoxycholic acid, Process IV
2023-03-31
Japanese DMF

Found JDMF

227MF10156
Ursodeoxycholic acid at 12, BONGEUN...
2015-06-18
Written Confirmation

Close WC

Application Number
28994
227MF10156
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
URSODIOL USP (PROCESS IV)
Ursodeoxycholic acid, Process IV
Ursodeoxycholic acid at 12, BONGEUN...
Issue/Submission Date
2015-02-10
2023-03-31
2015-06-18
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USDMF

Caution USDMF

21434
Inactive
URSODIOL USP (URSODEOXYCHOLIC ACID)
2008-03-17
CEP/COS

Found CEP/COS

R0-CEP 2020-134 - Rev 00
Valid
Ursodeoxycholic acid, Process III
2021-09-03
Japanese DMF

Found JDMF

305MF10072
Ursodeoxocholic acid at 12, BONGEUN...
2023-06-07
Written Confirmation

Close WC

Application Number
21434
305MF10072
Status
Inactive
Fees Unpaid
N/A
Valid
 
Filing Details
URSODIOL USP (URSODEOXYCHOLIC ACID)
Ursodeoxycholic acid, Process III
Ursodeoxocholic acid at 12, BONGEUN...
Issue/Submission Date
2008-03-17
2021-09-03
2023-06-07
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2011-354 - Rev 00
Valid
Ursodeoxycholic acid
2018-07-30
Japanese DMF

Found JDMF

226MF10088
Ursodeoxycholic acid at 12, BONGEUN...
2014-05-09
Written Confirmation

Close WC

Application Number
226MF10088
Status
Valid
 
Filing Details
Ursodeoxycholic acid
Ursodeoxycholic acid at 12, BONGEUN...
Issue/Submission Date
2018-07-30
2014-05-09
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USDMF

Caution USDMF

13772
Inactive
AMOXICILLIN
1998-09-01
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

221MF10239
Amoxicillin hydrate at 12 BONGEUNSA...
2009-11-09
Written Confirmation

Close WC

Application Number
13772
221MF10239
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
AMOXICILLIN
Amoxicillin hydrate at 12 BONGEUNSA...
Issue/Submission Date
1998-09-01
2009-11-09
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

218MF11025
[Japanese Pharmacopoeia] ampicillin...
2006-12-28
Written Confirmation

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Application Number
218MF11025
Status
 
Filing Details
[Japanese Pharmacopoeia] ampicillin...
Issue/Submission Date
2006-12-28
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

219MF10384
Cefotiam hydrochloride at 163-3, SA...
2007-12-19
Written Confirmation

Close WC

Application Number
219MF10384
Status
 
Filing Details
Cefotiam hydrochloride at 163-3, SA...
Issue/Submission Date
2007-12-19
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

219MF10378
Ceftriaxone sodium at 163-3, SAMSUN...
2007-12-19
Written Confirmation

Close WC

Application Number
219MF10378
Status
 
Filing Details
Ceftriaxone sodium at 163-3, SAMSUN...
Issue/Submission Date
2007-12-19
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2003-114 - Rev 00
Valid
Cefuroxime axetil
2011-02-04
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Cefuroxime axetil
Issue/Submission Date
2011-02-04
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

218MF11024
[Japanese Pharmacopoeia] cloxacilli...
2006-12-28
Written Confirmation

Close WC

Application Number
218MF11024
Status
 
Filing Details
[Japanese Pharmacopoeia] cloxacilli...
Issue/Submission Date
2006-12-28
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

218MF10402
Lansoprazole at 12, BONGEUNSA-RO, 1...
2006-04-14
Written Confirmation

Close WC

Application Number
218MF10402
Status
 
Filing Details
Lansoprazole at 12, BONGEUNSA-RO, 1...
Issue/Submission Date
2006-04-14
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USDMF

Caution USDMF

25679
Inactive
STERILE MEROPENEM
2012-01-05
CEP/COS

Caution CEP/COS

R0-CEP 2011-361 - Rev 00
Withdrawn by Holder
Meropenem trihydrate
2014-05-20
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
25679
Status
Inactive
Fees Unpaid
N/A
Withdrawn by Holder
 
Filing Details
STERILE MEROPENEM
Meropenem trihydrate
Issue/Submission Date
2012-01-05
2014-05-20
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

221MF10024
Rabeprazole Sodium at 12, BONGEUNSA...
2009-01-28
Written Confirmation

Close WC

Application Number
221MF10024
Status
 
Filing Details
Rabeprazole Sodium at 12, BONGEUNSA...
Issue/Submission Date
2009-01-28
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

229MF10216
Rabeprazole sodium at 12, BONGEUNSA...
2017-12-08
Written Confirmation

Close WC

Application Number
229MF10216
Status
 
Filing Details
Rabeprazole sodium at 12, BONGEUNSA...
Issue/Submission Date
2017-12-08
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USDMF

Caution USDMF

25680
Inactive
IOPROMIDE
2012-01-05
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
25680
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
IOPROMIDE
Issue/Submission Date
2012-01-05
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USDMF

Caution USDMF

26538
Inactive
STERILE MEROPENEM FOR INFECTION
2012-10-08
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
26538
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
STERILE MEROPENEM FOR INFECTION
Issue/Submission Date
2012-10-08
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USDMF

Caution USDMF

6017
Inactive
TRIMETHOPRIM
1985-09-12
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
6017
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
TRIMETHOPRIM
Issue/Submission Date
1985-09-12
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