01 1Ajanta Pharma Limited
02 1Albemarle Corporation
03 1Angene International
04 1Cambrex Corporation
05 1Grace
06 2Pfizer Inc
07 1Quimica Sintetica
08 1Shaanxi Baoxin Pharmaceutical
09 1Yung Shin Pharmaceutical Industrial
10 1Blank
01 2China
02 1India
03 1Spain
04 5U.S.A
05 1United Kingdom
06 1Blank
01 2Active
02 5Inactive
03 4Blank
01 11Blank
01 11Blank
01 11Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22795
Submission : 2009-03-23
Status : Active
Type : II
NDC Package Code : 63126-301
Start Marketing Date : 2009-03-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-07-24
Pay. Date : 2020-01-13
DMF Number : 5584
Submission : 1984-11-13
Status : Active
Type : II
NDC Package Code : 22568-1018
Start Marketing Date : 2021-06-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6871
Submission : 1987-03-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6857
Submission : 1987-03-09
Status : Inactive
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 : 5741
Submission : 1985-03-11
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 : 3709
Submission : 1980-02-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8144
Submission : 1989-07-26
Status : Inactive
Type : II
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