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// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219583

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207375
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-07-21
Pay. Date : 2021-07-06
DMF Number : 33973
Submission : 2019-08-13
Status : Active
Type : II
Certificate Number : R0-CEP 2019-211 - Rev 00
Issue Date : 2022-06-03
Type : Chemical
Substance Number : 2583
Status : Valid
Registration Number : 303MF10148
Registrant's Address : No. 1, North Outer Ring Road, Feixian County, Shandong Province, China
Initial Date of Registration : 2021-09-17
Latest Date of Registration :
Registrant Name : DM Co., Ltd.
Registration Date : 2025-03-11
Registration Number : 20250311-209-J-1803
Manufacturer Name : Shandong New Time Pharmaceutical Co.,Ltd.
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-29
Pay. Date : 2014-02-13
DMF Number : 25714
Submission : 2012-01-16
Status : Active
Type : II
Certificate Number : CEP 2011-375 - Rev 03
Issue Date : 2025-03-11
Type : Chemical
Substance Number : 1653
Status : Valid
NDC Package Code : 42677-105
Start Marketing Date : 2007-02-18
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (0.5kg/kg)
Marketing Category : BULK INGREDIENT FOR ...
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2017-10-25
Registration Number : 20120615-113-F-68-17(4)
Manufacturer Name : Shandong New Time Pharmaceutical Co.,Ltd.
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25718
Submission : 2012-01-16
Status : Active
Type : II
Certificate Number : CEP 2011-376 - Rev 03
Issue Date : 2025-03-17
Type : Chemical
Substance Number : 1653
Status : Valid
Registrant Name : Boryeong Co., Ltd.
Registration Date : 2017-07-27
Registration Number : 20120615-113-F-68-17(3)
Manufacturer Name : Shandong New Time Pharmaceutical Co.,Ltd.
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18995
Submission : 2005-11-28
Status : Active
Type : II
Certificate Number : CEP 2010-078 - Rev 02
Issue Date : 2026-03-04
Type : Chemical
Substance Number : 1673
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-10-28
Pay. Date : 2025-09-16
DMF Number : 41899
Submission : 2025-09-03
Status : Active
Type : II
Registration Number : 307MF10078
Registrant's Address : No. 1, North Outer Ring Road, Feixian County, Shandong Province, China
Initial Date of Registration : 2025-07-09
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19425
Submission : 2006-04-20
Status : Active
Type : II
Registration Number : 304MF10119
Registrant's Address : No. 1, North Outer Ring Road, Feixian County, Shandong Province, China
Initial Date of Registration : 2022-08-10
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36615
Submission : 2021-12-20
Status : Active
Type : II
Registration Number : 304MF10137
Registrant's Address : No. 1, North Outer Ring Road, Feixian County, Shandong Province, China
Initial Date of Registration : 2022-10-05
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23847
Submission : 2010-05-20
Status : Active
Type : II
Certificate Number : R0-CEP 2021-177 - Rev 00
Issue Date : 2022-08-26
Type : Chemical
Substance Number : 2743
Status : Valid
Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2022-09-16
Registration Number : 20220916-210-J-1363
Manufacturer Name : Shandong New Time Pharmaceutical Co., Ltd.
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China.

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19677
Submission : 2006-06-16
Status : Inactive
Type : II
Certificate Number : CEP 2011-374 - Rev 01
Issue Date : 2025-03-11
Type : Chemical
Substance Number : 1140
Status : Valid
NDC Package Code : 42677-104
Start Marketing Date : 2007-02-18
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (0.5kg/kg)
Marketing Category : DRUG FOR FURTHER PRO...
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2018-01-16
Registration Number : 20120615-113-F-69-16(1)
Manufacturer Name : Shandong New Time Pharmaceutical Co.,Ltd.
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20816
Submission : 2007-08-24
Status : Inactive
Type : II
Certificate Number : R0-CEP 2020-153 - Rev 00
Issue Date : 2022-05-11
Type : Chemical
Substance Number : 1118
Status : Valid
NDC Package Code : 42677-101
Start Marketing Date : 2011-02-18
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (0.6kg/kg)
Marketing Category : DRUG FOR FURTHER PRO...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20350
Submission : 2007-03-13
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21138
Submission : 2007-12-12
Status : Inactive
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2025-10-28
Pay. Date : 2025-09-22
DMF Number : 39831
Submission : 2024-05-08
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39830
Submission : 2024-05-19
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2023-07-05
Pay. Date : 2023-05-15
DMF Number : 38290
Submission : 2023-05-16
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25718
Submission : 2012-01-16
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2025-11-13
Pay. Date : 2025-09-23
DMF Number : 42075
Submission : 2025-07-25
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38625
Submission : 2023-08-17
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40290
Submission : 2024-09-03
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2024-03-12
Pay. Date : 2024-01-31
DMF Number : 36099
Submission : 2021-12-05
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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CEP/COS
Certificate Numbers : R0-CEP 2008-309 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2010-05-17
Type : Chemical
Substance Number : 1287

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CEP/COS
Certificate Numbers : CEP 2010-078 - Rev 02
Status : Valid
Issue Date : 2026-03-04
Type : Chemical
Substance Number : 1673

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Certificate Numbers : R0-CEP 2020-153 - Rev 00
Status : Valid
Issue Date : 2022-05-11
Type : Chemical
Substance Number : 1118

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CEP/COS
Certificate Numbers : R0-CEP 2019-211 - Rev 00
Status : Valid
Issue Date : 2022-06-03
Type : Chemical
Substance Number : 2583

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CEP/COS
Certificate Numbers : CEP 2011-374 - Rev 01
Status : Valid
Issue Date : 2025-03-11
Type : Chemical
Substance Number : 1140

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Certificate Numbers : CEP 2011-375 - Rev 03
Status : Valid
Issue Date : 2025-03-11
Type : Chemical
Substance Number : 1653

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Certificate Numbers : CEP 2011-376 - Rev 03
Status : Valid
Issue Date : 2025-03-17
Type : Chemical
Substance Number : 1653

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CEP/COS
Certificate Numbers : CEP 2012-234 - Rev 01
Status : Valid
Issue Date : 2025-03-04
Type : Chemical
Substance Number : 2269

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CEP/COS
Certificate Numbers : R0-CEP 2021-177 - Rev 00
Status : Valid
Issue Date : 2022-08-26
Type : Chemical
Substance Number : 2743

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Registrant Name : Daewoong Bio Co., Ltd.
Registration Date : 2018-10-08
Registration Number : 20181008-117-G-151-11
Manufacturer Name : Shandong Luoxin Pharmaceutical...
Manufacturer Address : West Side of Yanbin Road, Economic Development Zone, Feixian Linyi, Shandong PR China...

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Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2026-01-08
Registration Number : 20260108-209-J-2094
Manufacturer Name : Shandong New Time Pharmaceutic...
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong, China

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Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2025-01-13
Registration Number : 20230623-211-J-1342(A)
Manufacturer Name : Lunan New Time Bio-Tech Co., L...
Manufacturer Address : No.2, North Outer Ring Road, Feixian, County, Shandong Province, China

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Registrant Name : Daehan Newpharm Co., Ltd.
Registration Date : 2023-06-23
Registration Number : 20230623-211-J-1342
Manufacturer Name : Lunan New Time Bio-Tech Co., L...
Manufacturer Address : No.2, North Outer Ring Road, Feixian, County, Shandong Province

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Registrant Name : DM Co., Ltd.
Registration Date : 2025-03-11
Registration Number : 20250311-209-J-1803
Manufacturer Name : Shandong New Time Pharmaceutic...
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China

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Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2020-07-03
Registration Number : 20200703-209-J-544
Manufacturer Name : Shandong New Time Pharmaceutic...
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China

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Registrant Name : Boryeong Co., Ltd.
Registration Date : 2014-04-10
Registration Number : 20120615-113-F-67-18(3)
Manufacturer Name : Shandong New Time Pharmaceutic...
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China

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Registrant Name : Boryeong Co., Ltd.
Registration Date : 2017-07-27
Registration Number : 20120615-113-F-68-17(3)
Manufacturer Name : Shandong New Time Pharmaceutic...
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China

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Registrant Name : Penmix Co., Ltd.
Registration Date : 2013-01-31
Registration Number : 20120615-113-F-68-17(2)
Manufacturer Name : Shandong New Time Pharmaceutic...
Manufacturer Address : No.1 North Outer Ring Road, Feixian County, Shandong Province

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Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2018-01-16
Registration Number : 20120615-113-F-69-16(1)
Manufacturer Name : Shandong New Time Pharmaceutic...
Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China

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Regulatory Info :
Registration Country : USA
Dosage Form : TABLET
Brand Name : BRIVARACETAM
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number : 219583
Regulatory Info :
Registration Country : USA

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Regulatory Info :
Registration Country : USA
Dosage Form : TABLET
Brand Name : BRIVARACETAM
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number : 219583
Regulatory Info :
Registration Country : USA

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Regulatory Info :
Registration Country : USA
Dosage Form : TABLET
Brand Name : BRIVARACETAM
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number : 219583
Regulatory Info :
Registration Country : USA

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Regulatory Info :
Registration Country : USA
Dosage Form : TABLET
Brand Name : BRIVARACETAM
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number : 219583
Regulatory Info :
Registration Country : USA

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Regulatory Info :
Registration Country : USA
Dosage Form : TABLET
Brand Name : BRIVARACETAM
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number : 219583
Regulatory Info :
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : LIQUID;INHALATION
Brand Name : ISOFLURANE
Dosage Strength : 99.9%
Packaging :
Approval Date : 2025-11-04
Application Number : 216527
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET, EXTENDED RELEASE...
Brand Name : ISOSORBIDE MONONITRATE
Dosage Strength : 120MG
Packaging :
Approval Date : 2022-04-29
Application Number : 214115
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET, EXTENDED RELEASE...
Brand Name : ISOSORBIDE MONONITRATE
Dosage Strength : 30MG
Packaging :
Approval Date : 2024-02-08
Application Number : 214115
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET, EXTENDED RELEASE...
Brand Name : ISOSORBIDE MONONITRATE
Dosage Strength : 60MG
Packaging :
Approval Date : 2024-02-08
Application Number : 214115
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : MILRINONE LACTATE
Dosage Strength : EQ 1MG BASE/ML
Packaging :
Approval Date : 2023-01-23
Application Number : 216373
Regulatory Info : RX
Registration Country : USA

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients
Inspections and registrations
Country : China
City/Region : Feixian County
Audit Date : 2026-05-26
Audit Type : On-Site
Country : China
City/Region : Shandong
Audit Date : 2024-04-29
Audit Type : On-Site
Country : China
City/Region : Linyi
Audit Date : Jul-23
Audit Type : On-Site
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
Lunan Pharmaceutical is a supplier offers 82 products (APIs, Excipients or Intermediates).
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