01 1GLAND PHARMA LIMITED
02 1Hetero Drugs
03 1MSN Laboratories
04 1Olon S.p.A
05 1Shouyuan Chemical
06 1Zhejiang Ausun Pharmaceutical
01 2China
02 3India
03 1Italy
01 2Active
02 4Blank
01 6Blank
01 6Blank
01 1WC-0383A4
02 5Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-22
Pay. Date : 2018-11-13
DMF Number : 33295
Submission : 2018-11-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-06-04
Pay. Date : 2019-04-10
DMF Number : 33317
Submission : 2018-11-29
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 : 69766-060
Start Marketing Date : 2018-11-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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