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22 Feb 2023
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23235
Submission : 2009-10-30
Status : Active
Type : II
RLD : Yes
TE Code :
Dosage Form : SOLUTION; INTRAVENOUS
Proprietary Name : ASCOR
Dosage Strength : 25,000MG/50ML (500MG/ML)
Approval Date : 2017-10-02
Application Number : 209112
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Inspections and registrations
District Decision : No Action Indicated
Inspection End Date : 2014-03-27
City : Santa Ana
State : CA
Country/Area : US
Zip : 92704-6995
District : LOS
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2014-03-27
District Decision : No Action Indicated
Inspection End Date : 2013-05-31
City : Santa Ana
State : CA
Country/Area : US
Zip : 92704-6995
District : LOS
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2013-05-31
District Decision : No Action Indicated
Inspection End Date : 2012-08-16
City : Santa Ana
State : CA
Country/Area : US
Zip : 92704-6995
District : LOS
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2012-08-16
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-08-24
City : Santa Ana
State : CA
Country/Area : US
Zip : 92704-6995
District : LOS
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-08-24
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-08-24
City : Santa Ana
State : CA
Country/Area : US
Zip : 92704-6995
District : LOS
Center : CDER
Project Area : Unapproved and Misbranded Drugs
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-08-24
District Decision : Voluntary Action Indicated
Inspection End Date : 2010-06-02
City : Santa Ana
State : CA
Country/Area : US
Zip : 92704-6995
District : LOS
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2010-06-02
District Decision : Voluntary Action Indicated
Inspection End Date : 2010-06-02
City : Santa Ana
State : CA
Country/Area : US
Zip : 92704-6995
District : LOS
Center : CDER
Project Area : Unapproved and Misbranded Drugs
District Decision : Voluntary Action Indicated
Inspection End Date : 2010-06-02
ABOUT THIS PAGE
McGuff Pharmaceuticals is a supplier offers 1 products (APIs, Excipients or Intermediates).
Find a price of Ascorbic Acid bulk with DMF offered by McGuff Pharmaceuticals