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[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/our-unmatched-efficiency-and-track-record-of-faster-dmf-filings-give-our-customers-a-critical-competitive-advantage
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14 Mar 2025
// REUTERS
https://www.reuters.com/business/healthcare-pharmaceuticals/drugmakers-mallinckrodt-endo-merge-nearly-7-billion-deal-2025-03-13/
13 Mar 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/mallinckrodt-plc-reports-fourth-quarter-and-fiscal-year-2024-financial-results-and-provides-2025-guidance-302400719.html
10 Mar 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/mallinckrodt-plc-reschedules-release-of-fourth-quarter-and-fiscal-year-2024-financial-results-to-thursday-march-13-2025-302397490.html
02 Dec 2024
// BUSINESSWIRE
02 Dec 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/mallinckrodt-completes-divestiture-of-therakos-business-302319183.html
18 Nov 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/mallinckrodt-presents-data-on-terlivaz-terlipressin-for-injection-in-patients-with-hepatorenal-syndrome-hrs-at-the-2024-american-association-for-the-study-of-liver-diseases-aasld-annual-meeting-302308532.html
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21820
Submission : 2008-07-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7889
Submission : 1989-01-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3534
Submission : 1979-04-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5683
Submission : 1985-01-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9476
Submission : 1991-12-31
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-11
Pay. Date : 2012-11-27
DMF Number : 5326
Submission : 1984-04-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7047
Submission : 1987-06-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7056
Submission : 1987-06-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4499
Submission : 1982-04-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12621
Submission : 1997-08-12
Status : Inactive
Type : II
Excipients
REF. STANDARDS & IMPURITIES
Inspections and registrations
District Decision : No Action Indicated
Inspection End Date : 2015-07-07
City : Cincinnati
State : OH
Country/Area : US
Zip : 45237-1624
District : CIN
Center : CDRH
Project Area : Compliance: Devices
District Decision : No Action Indicated
Inspection End Date : 2015-07-07
District Decision : No Action Indicated
Inspection End Date : 2015-07-07
City : Cincinnati
State : OH
Country/Area : US
Zip : 45237-1624
District : CIN
Center : CDRH
Project Area : Postmarket Assurance: Devices
District Decision : No Action Indicated
Inspection End Date : 2015-07-07
District Decision : No Action Indicated
Inspection End Date : 2014-07-25
City : Raleigh
State : NC
Country/Area : US
Zip : 27616-3104
District : ATL
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2014-07-25
District Decision : No Action Indicated
Inspection End Date : 2014-06-18
City : Maryland Heights
State : MO
Country/Area : US
Zip : 63043-3421
District : KAN
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2014-06-18
District Decision : No Action Indicated
Inspection End Date : 2014-06-18
City : Hazelwood
State : MO
Country/Area : US
Zip : 63042-2513
District : KAN
Center : CDRH
Project Area : Compliance: Devices
District Decision : No Action Indicated
Inspection End Date : 2014-06-18
District Decision : No Action Indicated
Inspection End Date : 2014-06-18
City : Hazelwood
State : MO
Country/Area : US
Zip : 63042-2513
District : KAN
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2014-06-18
District Decision : No Action Indicated
Inspection End Date : 2014-06-18
City : Maryland Heights
State : MO
Country/Area : US
Zip : 63043-3421
District : KAN
Center : CDRH
Project Area : Compliance: Devices
District Decision : No Action Indicated
Inspection End Date : 2014-06-18
District Decision : No Action Indicated
Inspection End Date : 2014-06-12
City : Saint Louis
State : MO
Country/Area : US
Zip : 63147-3457
District : KAN
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2014-06-12
District Decision : No Action Indicated
Inspection End Date : 2013-05-24
City : Saint Louis
State : MO
Country/Area : US
Zip : 63147-3457
District : KAN
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2013-05-24
District Decision : No Action Indicated
Inspection End Date : 2013-03-27
City : Maryland Heights
State : MO
Country/Area : US
Zip : 63043-3421
District : KAN
Center : CDRH
Project Area : Compliance: Devices
District Decision : No Action Indicated
Inspection End Date : 2013-03-27
Type : GMP Certificates
Number : UK GMP 2042...
EudraGMDP Key : 10803
Country : U.S.A
Issue Date :
Post Code : 62246
NCA Ref : 13486-MALLIN...
City : GREENVILLE
Type : GMP Certificates
Number : 2013/7285
EudraGMDP Key : 7884
Country : U.S.A
Issue Date :
Post Code : 27616
NCA Ref : 7.8841257857...
City : Raleigh
Type : GMP Certificates
Number : 2012/5313
EudraGMDP Key : 9182
Country : U.S.A
Issue Date :
Post Code : 27616
NCA Ref : 17236-MALLIN...
City : RALEIGH
Type : GMP Certificates
Number : UK GMP 2042...
EudraGMDP Key : 10994
Country : U.S.A
Issue Date :
Post Code : 13788
NCA Ref : 12820-MALLIN...
City : HOBART
Type : GMP Certificates
Number : UK API 6538...
EudraGMDP Key : 9182
Country : U.S.A
Issue Date :
Post Code : 27616
NCA Ref : 17236-MALLIN...
City : RALEIGH
ABOUT THIS PAGE
Mallinckrodt Plc is a supplier offers 154 products (APIs, Excipients or Intermediates).
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