01 1Actavis Inc
02 1BOC Sciences
03 1CSL Vifor
04 1Fengchen Group
05 1Fison
06 1GLAND PHARMA LIMITED
07 1Micro Orgo Chem
08 2Pharmacosmos AS
09 1Swati Spentose
10 1Viatris
11 1West Bengal Chemicals Industries
12 1Zhejiang Apeloa Jiayuan Pharmaceutical
13 2Blank
01 2China
02 2Denmark
03 4India
04 1Ireland
05 1Switzerland
06 2U.S.A
07 1United Kingdom
08 2Blank
01 4Active
02 6Inactive
03 5Blank
01 15Blank
01 15Blank
01 1WC-0356
02 14Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29214
Submission : 2015-03-20
Status : Active
Type : II
NDC Package Code : 12666-0020
Start Marketing Date : 2011-12-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-06-12
Pay. Date : 2019-04-30
DMF Number : 33358
Submission : 2018-11-27
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-06-15
Pay. Date : 2015-07-28
DMF Number : 27823
Submission : 2015-06-10
Status : Active
Type : II
Date of Issue : 2020-02-10
Valid Till : 2022-02-02
Written Confirmation Number : WC-0356
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-10-20
Pay. Date : 2023-10-17
DMF Number : 8364
Submission : 1989-12-29
Status : Active
Type : II
VMF Number : 3829
Submission : 1985-02-21
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7608
Submission : 1988-07-28
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10075
Submission : 1993-02-05
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8808
Submission : 1990-10-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12295
Submission : 1996-12-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1601
Submission : 1970-10-26
Status : Inactive
Type : II
VMF Number : 3829
Submission : 1985-02-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3774
Submission : 1980-03-28
Status : Inactive
Type : II
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