01 2ALP Pharm
02 1Actavis Inc
03 1Aurobindo Pharma Limited
04 1MSN Laboratories
01 2China
02 2India
03 1Ireland
01 2Active
02 2Inactive
03 1Blank
01 5Blank
01 5Blank
01 1WC-0383A4
02 4Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-19
Pay. Date : 2016-05-18
DMF Number : 30553
Submission : 2016-05-24
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-05
Pay. Date : 2020-09-29
DMF Number : 30563
Submission : 2016-05-31
Status : Active
Type : II
Date of Issue : 2019-10-15
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383A4
Address of the Firm :
NDC Package Code : 69766-012
Start Marketing Date : 2016-05-23
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 : 24035
Submission : 2010-07-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25908
Submission : 2012-04-02
Status : Inactive
Type : II
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