Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 2Pfanstiehl
02 1Durect Corporation
03 3Fagron Group
04 1Freund Vector Corporation
05 1Hubei Gedian Humanwell Pharmaceutical
06 1JRS Pharma
07 1Mitsubishi Chemical Holdings Corporation
01 5Active
02 2Inactive
03 3Blank
01 10Blank
01 10Blank
01 10Blank
01 10Blank
01 151552-1414
02 151552-1527
03 151552-1530
04 7Blank
01 10Blank
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19538
Submission : 2006-06-20
Status : Active
Type : IV
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37676
Submission : 2022-11-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16697
Submission : 2003-07-09
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18881
Submission : 2005-10-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36348
Submission : 2021-11-03
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11797
Submission : 1995-10-27
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14975
Submission : 2000-07-31
Status : Inactive
Type : IV
NDC Package Code : 51552-1527
Start Marketing Date : 2016-09-15
End Marketing Date : 2027-07-07
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
NDC Package Code : 51552-1530
Start Marketing Date : 2016-12-28
End Marketing Date : 2025-11-08
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
NDC Package Code : 51552-1414
Start Marketing Date : 2012-04-01
End Marketing Date : 2027-04-15
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
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