01 1Arch Pharmalabs
02 1Aspire Lifesciences Pvt Ltd
03 2Aurobindo Pharma Limited
04 1Cipla
05 1ERREDUE S.P.A. IT 24040 Isso
06 1Hetero Drugs
07 1RANBAXY LABORATORIES LIMITED
08 1SEQUENT SCIENTIFIC LTD
09 1SIBRA PHARMACEUTICALS LTD
10 1ST Pharma
11 1Shanghai Desano Bio-Pharmaceutical
12 3Viatris
01 1China
02 9India
03 1Italy
04 1South Korea
05 3U.S.A
01 5Active
02 9Inactive
03 1Blank
01 1Withdrawn by Holder
02 14Blank
01 15Blank
01 1WC-0041
02 1WC-0118
03 13Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19863
Submission : 2006-10-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20107
Submission : 2007-01-02
Status : Active
Type : II
NDC Package Code : 65015-672
Start Marketing Date : 2015-01-12
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 : 20423
Submission : 2007-03-17
Status : Active
Type : II
NDC Package Code : 65015-672
Start Marketing Date : 2015-01-12
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 : 20087
Submission : 2006-12-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17976
Submission : 2004-01-06
Status : Inactive
Type : II
Date of Issue : 2019-08-05
Valid Till : 2022-08-04
Written Confirmation Number : WC-0118
Address of the Firm :
NDC Package Code : 65015-672
Start Marketing Date : 2015-01-12
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 : 17997
Submission : 2005-01-17
Status : Inactive
Type : II
Certificate Number : R1-CEP 2008-162 - Rev 02
Issue Date : 2017-08-10
Type : Chemical
Substance Number : 2130
Status : Withdrawn by Holder
Date of Issue : 2022-09-16
Valid Till : 2025-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21279
Submission : 2008-01-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21616
Submission : 2008-05-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23085
Submission : 2009-09-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26529
Submission : 2012-10-08
Status : Inactive
Type : II
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