01 1Arene Lifesciences
02 1Cipla
03 1Hetero Drugs
04 1Laurus Labs
05 1Lupin Ltd
06 1MSN Laboratories
07 1Mangalam Drugs & Organics Ltd
08 1Viatris
09 1Zhejiang Tianyu Pharmaceutical Co., Ltd
01 1China
02 7India
03 1U.S.A
01 6Active
02 3Blank
01 9Blank
01 9Blank
01 1WC-0213
02 8Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-01-26
Pay. Date : 2021-11-24
DMF Number : 36444
Submission : 2021-12-24
Status : Active
Type : II
Date of Issue : 2023-07-03
Valid Till : 2025-07-02
Written Confirmation Number : WC-0213
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-07-06
Pay. Date : 2021-05-28
DMF Number : 35866
Submission : 2021-05-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37428
Submission : 2022-09-16
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-05-26
Pay. Date : 2021-04-28
DMF Number : 35795
Submission : 2021-04-09
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-08-26
Pay. Date : 2019-06-06
DMF Number : 33906
Submission : 2019-07-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35655
Submission : 2021-02-27
Status : Active
Type : II
NDC Package Code : 69766-097
Start Marketing Date : 2021-02-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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