01 1Cahaya Mandiri Farma
02 2Fison
03 3MEITO SANGYO CO LTD
04 4Pharmacosmos AS
05 1SAFC
06 1Swati Spentose
07 3Xian Wanlong Pharmaceutical Co. Ltd
08 4Blank
01 3China
02 4Denmark
03 1India
04 1Indonesia
05 3Japan
06 1U.S.A
07 2United Kingdom
08 4Blank
01 1Active
02 7Inactive
03 11Blank
01 4Valid
02 15Blank
01 1217MF11169
02 1218MF10826
03 1218MF10831
04 16Blank
01 19Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19584
Submission : 2006-06-30
Status : Active
Type : II
Certificate Number : R1-CEP 1999-063 - Rev 03
Issue Date : 2022-01-03
Type : Chemical
Substance Number : 999
Status : Valid
NDC Package Code : 49442-5001
Start Marketing Date : 2011-11-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : DRUG FOR FURTHER PROCESSING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1183
Submission : 1968-05-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1184
Submission : 1968-05-07
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 353
Submission : 1959-11-16
Status : Inactive
Type : II
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Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 462
Submission : 1962-01-08
Status : Inactive
Type : II
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Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2573
Submission : 1975-12-03
Status : Inactive
Type : II
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Virtual Booth
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 9447
Submission : 1991-12-05
Status : Inactive
Type : II
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Website
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23092
Submission : 2009-07-31
Status : Inactive
Type : II
Certificate Number : R1-CEP 1999-064 - Rev 03
Issue Date : 2022-01-03
Type : Chemical
Substance Number : 1000
Status : Valid
NDC Package Code : 49442-5001
Start Marketing Date : 2011-11-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : DRUG FOR FURTHER PROCESSING
Certificate Number : R1-CEP 1999-065 - Rev 03
Issue Date : 2022-01-03
Type : Chemical
Substance Number : 1001
Status : Valid
NDC Package Code : 49442-5001
Start Marketing Date : 2011-11-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : DRUG FOR FURTHER PROCESSING
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