01 1Alembic Pharmaceuticals Limited
02 1Apicore LLC
03 1Beijing Sjar Technology Development
04 1DEAFARMA
05 1Hetero Drugs
06 1MSN Laboratories
07 1Shandong Haohong Biotechnology Co.,ltd
08 1Sichuan Qingmu Pharmaceutical
09 1Signa S.A. de C.V.
10 1Viatris
01 3China
02 4India
03 1Italy
04 1Mexico
05 1U.S.A
01 3Active
02 7Blank
01 10Blank
01 10Blank
01 1WC-0110n
02 1WC-0349
03 8Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2021-01-29
Pay. Date : 2020-11-27
DMF Number : 35413
Submission : 2020-12-16
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-07-22
Pay. Date : 2022-06-06
DMF Number : 32340
Submission : 2018-01-07
Status : Active
Type : II
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Rev. Date :
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DMF Number : 37854
Submission : 2022-12-31
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 : 54893-0124
Start Marketing Date : 2022-12-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-07-15
Valid Till : 2025-07-02
Written Confirmation Number : WC-0110n
Address of the Firm :
NDC Package Code : 42973-242
Start Marketing Date : 2017-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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