01 1Anax Laboratories
02 1Epoch Labs
03 1Haoyuan Chemexpress Co.Ltd
04 1Hetero Drugs
05 1Teva API
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 : 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
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
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