01 1Corden Pharma Bergamo S.p.A
02 1DK Pharmachem Pvt. Ltd
03 1Emcure Pharmaceuticals
04 1F.I.S. Fabbrica Italiana Sintetici
05 1Industriale Chimica
06 1Siegfried AG
01 2India
02 3Italy
03 1Switzerland
01 2Active
02 4Inactive
01 6Blank
01 6Blank
01 1WC-0226
02 5Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-19
Pay. Date : 2013-07-05
DMF Number : 26950
Submission : 2013-06-11
Status : Active
Type : II
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0226
Address of the Firm :
NDC Package Code : 14593-884
Start Marketing Date : 2020-04-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4088
Submission : 1981-02-27
Status : Active
Type : II
NDC Package Code : 17205-416
Start Marketing Date : 1981-02-27
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 : 19965
Submission : 2006-11-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7721
Submission : 1988-10-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27428
Submission : 2014-03-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4694
Submission : 1982-10-14
Status : Inactive
Type : II
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