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Digital content
INTERVIEW #SpeakPharma
[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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26 Aug 2024
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208112
25 Jun 2024
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204982
07 Feb 2024
// FDA
https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-7-2024-67267.pdf
16 Jan 2024
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208443
03 Apr 2023
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208906
05 Jan 2023
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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204855
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-24
Pay. Date : 2013-06-12
DMF Number : 7884
Submission : 1989-01-21
Status : Active
Type : II
Certificate Number : CEP 2017-101 - Rev 04
Issue Date : 2024-04-17
Type : Chemical
Substance Number : 1452
Status : Valid
NDC Package Code : 61252-3002
Start Marketing Date : 1994-02-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-10-25
Pay. Date : 2012-11-26
DMF Number : 10739
Submission : 1994-02-01
Status : Active
Type : II
Certificate Number : R0-CEP 2022-477 - Rev 00
Issue Date : 2023-08-21
Type : Chemical
Substance Number : 1792
Status : Valid
NDC Package Code : 61252-3002
Start Marketing Date : 1994-02-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14653
Submission : 2000-01-03
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-398 - Rev 00
Issue Date : 2007-02-23
Type : Chemical
Substance Number : 1300
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-16
Pay. Date : 2015-06-08
DMF Number : 29410
Submission : 2015-06-19
Status : Active
Type : II
Date of Issue : 2021-07-29
Valid Till : 2022-08-15
Written Confirmation Number : WC-0199A1
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22258
Submission : 2008-12-22
Status : Active
Type : II
Date of Issue : 2019-08-16
Valid Till : 2022-08-15
Written Confirmation Number : WC-0199
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22123
Submission : 2008-11-18
Status : Active
Type : II
Certificate Number : R0-CEP 2010-261 - Rev 00
Issue Date : 2013-01-22
Type : Chemical
Substance Number : 2154
Status : Withdrawn by EDQM F...
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16135
Submission : 2002-09-16
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15504
Submission : 2001-07-11
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16505
Submission : 2003-04-22
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-05-31
Pay. Date : 2018-04-29
DMF Number : 15772
Submission : 2001-12-18
Status : Active
Type : II
Regulatory Info :
Registration Country : Norway
Dosage Form : Infusion fluid, resolution
Dosage Strength : 10 mg/ml
Packaging : Hood glass
Brand Name : Acetaminophen Actavis
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Infusion fluid, resolution
Dosage Strength : 10 mg/ml
Packaging : Hood glass
Brand Name : Acetaminophen Actavis
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Granules
Dosage Strength : 1 g
Packaging : Dose Bag
Brand Name : Pinex
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Antic-calc Tablet
Dosage Strength : 500 mg
Packaging : Blister, endose
Brand Name : Pinex
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Antic-calc Tablet
Dosage Strength : 500 mg
Packaging : Blister, endose
Brand Name : Pinex
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Antic-calc Tablet
Dosage Strength : 500 mg
Packaging : Box
Brand Name : Pinex
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Sweden
Dosage Form : GASTRO
Dosage Strength : 150 MG
Packaging :
Brand Name : Aspirin Actavis
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Dosage Form : GASTRO
Dosage Strength : 75 MG
Packaging :
Brand Name : Peneprin
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Dosage Form : GASTRO
Dosage Strength : 100 MG
Packaging :
Brand Name : Peneprin
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Dosage Form : GASTRO
Dosage Strength : 150 MG
Packaging :
Brand Name : Peneprin
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Excipients
Inspections and registrations
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-09-22
City : Nantou County
State :
Country/Area : TW
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-09-22
District Decision : No Action Indicated
Inspection End Date : 2017-09-22
City : Weiterstadt
State :
Country/Area : DE
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2017-09-22
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-05-19
City : Elizabeth
State : NJ
Country/Area : US
Zip : 07202-1106
District : NWJ
Center : CDER
Project Area : Bioresearch Monitoring
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-05-19
District Decision : No Action Indicated
Inspection End Date : 2017-05-16
City : Navi Mumbai
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Bioresearch Monitoring
District Decision : No Action Indicated
Inspection End Date : 2017-05-16
District Decision : No Action Indicated
Inspection End Date : 2017-05-06
City : Navi Mumbai
State :
Country/Area : IN
Zip :
District : ORA
Center : CDER
Project Area : Bioresearch Monitoring
District Decision : No Action Indicated
Inspection End Date : 2017-05-06
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-03-10
City : Dublin 17
State :
Country/Area : IE
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-03-10
District Decision : No Action Indicated
Inspection End Date : 2017-03-03
City : Fajardo
State : PR
Country/Area : US
Zip : 00738
District : SJN
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2017-03-03
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-02-15
City : Elizabeth
State : NJ
Country/Area : US
Zip : 07202-1106
District : NWJ
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-02-15
District Decision : No Action Indicated
Inspection End Date : 2017-01-30
City : Corona
State : CA
Country/Area : US
Zip : 92880-2882
District : LOS
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2017-01-30
District Decision : No Action Indicated
Inspection End Date : 2015-09-22
City : Cincinnati
State : OH
Country/Area : US
Zip : 45209-1105
District : CIN
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2015-09-22
ABOUT THIS PAGE
Actavis Inc is a supplier offers 47 products (APIs, Excipients or Intermediates).
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