01 1Anax Laboratories
02 1Beijing Mesochem Technology
03 1Guangzhou Tosun Pharmaceutical
04 1Hetero Drugs
05 2MSN Laboratories
06 1TOPHARMAN SHANDONG CO LTD
07 1Tecoland Corporation
08 1Teva API
09 1Teva Pharmaceutical Industries
10 1Vannsh Life Sciences
01 3China
02 5India
03 2Israel
04 1U.S.A
01 3Active
02 8Blank
01 11Blank
01 11Blank
01 1WC-0349
02 1WC-0349A12
03 9Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37407
Submission : 2022-08-29
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-04-27
Pay. Date : 2020-12-17
DMF Number : 35457
Submission : 2021-01-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34652
Submission : 2020-02-28
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0096
Start Marketing Date : 2020-02-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2021-04-23
Valid Till : 2022-05-05
Written Confirmation Number : WC-0349A12
Address of the Firm :
NDC Package Code : 54893-0096
Start Marketing Date : 2020-02-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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