01 1Chemische Fabrik Berg
02 1Cambrex Corporation
03 1Chattem Chemicals, Inc
04 1Mallinckrodt Pharmaceuticals
05 1Pisgah Labs
06 2Sandoz B2B
07 1Siegfried AG
01 1Germany
02 1Ireland
03 3Switzerland
04 3U.S.A
01 3Active
02 5Inactive
01 8Blank
01 8Blank
01 8Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-06
Pay. Date : 2013-02-20
DMF Number : 4395
Submission : 1981-11-25
Status : Active
Type : II
NDC Package Code : 65319-1168
Start Marketing Date : 2015-07-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-04-18
Pay. Date : 2014-04-11
DMF Number : 15986
Submission : 2002-05-24
Status : Active
Type : II
NDC Package Code : 61960-7200
Start Marketing Date : 2002-05-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-11
Pay. Date : 2012-12-03
DMF Number : 1166
Submission : 1968-04-09
Status : Active
Type : II
NDC Package Code : 0792-0134
Start Marketing Date : 1968-04-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18086
Submission : 2005-02-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5610
Submission : 1984-12-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5645
Submission : 1984-12-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16209
Submission : 2002-10-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17054
Submission : 2003-12-12
Status : Inactive
Type : II
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