01 1Corden Pharma Bergamo S.p.A
02 1Globofarm International
03 1JRC
04 2Medigraph Pharmaceuticals Pvt. Ltd.
05 2Permachem Asia, Ltd
06 1Seratec SAS
07 1Siegfried AG
08 1Wockhardt
09 3Blank
01 1France
02 5India
03 1Italy
04 2Japan
05 1Switzerland
06 3Blank
01 3Active
02 4Inactive
03 6Blank
01 13Blank
01 1217MF10710
02 1224MF10220
03 11Blank
01 1WC-0075
02 1WC-0341
03 1WC-0341A2-A3
04 10Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15866
Submission : 2002-02-18
Status : Active
Type : II
NDC Package Code : 65732-121
Start Marketing Date : 2005-06-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-12-28
Pay. Date : 2018-12-20
DMF Number : 15737
Submission : 2001-11-21
Status : Active
Type : II
NDC Package Code : 17381-207
Start Marketing Date : 2010-05-13
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 : 16119
Submission : 2002-08-27
Status : Active
Type : II
Date of Issue : 2019-07-22
Valid Till : 2022-07-21
Written Confirmation Number : WC-0075
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GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 2501
Submission : 1975-07-25
Status : Inactive
Type : II
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : N/A
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DMF Number : 4348
Submission : 1981-12-08
Status : Inactive
Type : II
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Review : N/A
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DMF Number : 4766
Submission : 1982-12-10
Status : Inactive
Type : II
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GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 15213
Submission : 2000-12-20
Status : Inactive
Type : II
Date of Issue : 2020-01-02
Valid Till : 2022-07-22
Written Confirmation Number : WC-0341A2-A3
Address of the Firm :
Date of Issue : 2019-07-22
Valid Till : 2022-07-21
Written Confirmation Number : WC-0341
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