01 1Amster Microcell
02 1Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
03 1Huzhou Zhanwang Pharmaceutical
04 1MLA Group
05 1MLA Group of Industries
06 1Mallinckrodt Pharmaceuticals
07 1Neelkanth Finechem
08 2Nitika Pharmaceutical Specialities
09 1Prachin Chemical
10 1Roquette
11 1Shandong Liaocheng E Hua Pharmaceutical
12 1Sudeep Pharma
13 1Valtris
14 2Blank
01 15Active
02 1Inactive
01 16Blank
01 16Blank
01 16Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34101
Submission : 2020-05-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33148
Submission : 2018-10-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33392
Submission : 2018-12-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38148
Submission : 2023-06-01
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38164
Submission : 2023-05-12
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32690
Submission : 2018-04-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33414
Submission : 2019-05-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36261
Submission : 2021-09-01
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32441
Submission : 2018-01-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36212
Submission : 2021-09-10
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29612
Submission : 2015-06-25
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5894
Submission : 1985-06-13
Status : Active
Type : IV
NDC Package Code : 0406-2257
Start Marketing Date : 2003-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38953
Submission : 2023-09-27
Status : Active
Type : IV
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 : 35665
Submission : 2021-02-25
Status : Active
Type : IV
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 : 36717
Submission : 2022-01-20
Status : Active
Type : IV
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18912
Submission : 2005-10-24
Status : Inactive
Type : IV
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