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INTERVIEW #SpeakPharma
[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/due-to-its-20-year-mastery-in-micronization-inke-has-emerged-a-cornerstone-in-treating-global-respiratory-diseases
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22 Dec 2022
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103411
24 Jun 2020
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103411
https://www.pharmacompass.com/pdf/news/sigma-tau-arzneimittel-gmbh-chenodeoxycholic-acid-sigma-tau-receives-approval-in-europe-1494071739.pdf
08 Aug 2016
// PM LIVE
http://www.pmlive.com/pharma_appointments/sigma-tau_pharmaceuticals_appoints_ceo_1091722
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2384
Submission : 1975-01-03
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10442
Submission : 1993-08-17
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10658
Submission : 1994-01-06
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2570
Submission : 1975-07-21
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 10090
Submission : 1993-02-10
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2428
Submission : 1975-03-13
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10528
Submission : 1993-10-13
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10188
Submission : 1993-04-08
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2569
Submission : 1975-11-21
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 2342
Submission : 1974-10-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 3215
Submission : 1978-05-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2384
Submission : 1975-01-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10442
Submission : 1993-08-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4324
Submission : 1981-10-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3714
Submission : 1980-01-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5329
Submission : 1983-10-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7771
Submission : 1988-11-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3938
Submission : 1980-09-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2868
Submission : 1977-02-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7221
Submission : 1987-10-13
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Type : II
Inspections and registrations
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-04-19
City : Indianapolis
State : IN
Country/Area : US
Zip : 46268
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District Decision : Voluntary Action Indicated
Inspection End Date : 2013-04-19
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-11-07
City : Indianapolis
State : IN
Country/Area : US
Zip : 46268
District : DET
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2013-11-07
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-04-10
City : Indianapolis
State : IN
Country/Area : US
Zip : 46268
District : DET
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-04-10
District Decision : Voluntary Action Indicated
Inspection End Date : 2009-06-17
City : Indianapolis
State : IN
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Zip : 46268
District : DET
Center : CDER
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District Decision : Voluntary Action Indicated
Inspection End Date : 2009-06-17
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-06-07
City : Indianapolis
State : IN
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Zip : 46268
District : DET
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-06-07
District Decision : No Action Indicated
Inspection End Date : 2013-01-25
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State : MD
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Zip : 20878
District : BLT
Center : CDER
Project Area : Bioresearch Monitoring
District Decision : No Action Indicated
Inspection End Date : 2013-01-25
District Decision : No Action Indicated
Inspection End Date : 2010-08-17
City : Gaithersburg
State : MD
Country/Area : US
Zip : 20878
District : BLT
Center : CDER
Project Area : Bioresearch Monitoring
District Decision : No Action Indicated
Inspection End Date : 2010-08-17
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-05-16
City : Indianapolis
State : IN
Country/Area : US
Zip : 46268
District : DET
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-05-16
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-09-16
City : Pomezia
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Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-09-16
District Decision : Voluntary Action Indicated
Inspection End Date : 2010-06-04
City : Indianapolis
State : IN
Country/Area : US
Zip : 46268
District : DET
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2010-06-04
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