01 1Anax Laboratories
02 1Epoch Labs
03 1Haoyuan Chemexpress Co.Ltd
04 1Hetero Drugs
05 1TAPI Technology & API Services
01 1China
02 3India
03 1Israel
01 2Active
02 3Blank
01 5Blank
01 5Blank
01 1WC-0041
02 4Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-10
Pay. Date : 2013-07-16
DMF Number : 27298
Submission : 2013-08-23
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-14
Pay. Date : 2013-07-05
DMF Number : 27232
Submission : 2013-06-19
Status : Active
Type : II
Date of Issue : 2022-09-16
Valid Till : 2025-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
NDC Package Code : 68554-0071
Start Marketing Date : 2009-09-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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