01 1Emcure Pharmaceuticals
02 2Sai Life Sciences Limited
03 1Xian Libang Pharmaceutical Co.,Ltd
01 1China
02 3India
01 2Active
02 2Inactive
01 4Blank
01 4Blank
01 1WC-0130
02 3Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-16
Pay. Date : 2015-09-08
DMF Number : 21470
Submission : 2008-03-08
Status : Active
Type : II
NDC Package Code : 14474-040
Start Marketing Date : 2017-12-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25g/25g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25763
Submission : 2012-03-19
Status : Active
Type : II
NDC Package Code : 14593-858
Start Marketing Date : 2023-12-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20252
Submission : 2007-02-06
Status : Inactive
Type : II
Date of Issue : 2022-07-26
Valid Till : 2025-07-14
Written Confirmation Number : WC-0130
Address of the Firm :
NDC Package Code : 14474-040
Start Marketing Date : 2017-12-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25g/25g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21553
Submission : 2008-04-14
Status : Inactive
Type : II
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