01 2Corel Pharma Chem
02 1ION EXCHANGE INDIA LIMITED
03 1Jiangsu Kingshan New Material
04 1Purolite
01 5Active
01 5Blank
01 5Blank
01 5Blank
GDUFA
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DMF Number : 20526
Submission : 2007-05-11
Status : Active
Type : IV
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DMF Number : 33045
Submission : 2018-08-06
Status : Active
Type : IV
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DMF Number : 7940
Submission : 1989-02-21
Status : Active
Type : II
NDC Package Code : 68444-0003
Start Marketing Date : 2010-10-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (56kg/56kg)
Marketing Category : BULK INGREDIENT
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DMF Number : 29333
Submission : 2015-06-22
Status : Active
Type : IV
NDC Package Code : 55363-294
Start Marketing Date : 2015-04-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
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DMF Number : 37061
Submission : 2022-04-20
Status : Active
Type : IV
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