01 1CHEMICA INC
02 1Chattem Chemicals, Inc
03 1CordenPharma
04 1Emcure Pharmaceuticals
05 2Hoventa Pharma
06 1Mallinckrodt Pharmaceuticals
07 1Olon S.p.A
08 2Siegfried AG
01 1Germany
02 3India
03 1Ireland
04 1Italy
05 2Switzerland
06 2U.S.A
01 3Active
02 5Inactive
03 2Blank
01 10Blank
01 10Blank
01 1WC-0226A3
02 9Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23944
Submission : 2010-07-06
Status : Active
Type : II
Date of Issue : 2020-01-03
Valid Till : 2022-07-02
Written Confirmation Number : WC-0226A3
Address of the Firm :
NDC Package Code : 14593-837
Start Marketing Date : 2022-02-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (15kg/15kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18893
Submission : 2005-10-21
Status : Active
Type : II
NDC Package Code : 61960-7600
Start Marketing Date : 2003-02-01
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 : 21319
Submission : 2008-02-05
Status : Active
Type : II
NDC Package Code : 17337-0010
Start Marketing Date : 2018-11-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22040
Submission : 2008-09-29
Status : Inactive
Type : II
NDC Package Code : 0406-9223
Start Marketing Date : 2013-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5703
Submission : 1985-02-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20563
Submission : 2007-05-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16687
Submission : 2003-07-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21090
Submission : 2007-11-26
Status : Inactive
Type : II
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